Miscellaneous Clinical Trials

Trial MenuList of Available Trials:

 

SWOG 0702: “A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment”

OUTLINE:
This is a multicenter study.  Patients undergo dental assessments at baseline and every 3-6 months for 3 years.

RATIONALE:
Gathering information about how often osteonecrosis of the jaw occurs in patients receiving zoledronic acid for bone metastases may help doctors learn more about the disease and provide the best follow-up care.

PURPOSE:
This clinical trial is studying osteonecrosis of the jaw in patients with cancer who are receiving zoledronic acid for bone metastases.

ELIGIBILITY:

DISEASE CHARACTERISTICS:

  • Participant must have bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease
  • Treatment with osteoclast inhibition is clinically indicated
  • Must be planning to receive zoledronic acid* within the next 30 days NOTE: *Osteoclast inhibition therapy will continue thereafter as clinically indicated.
  • No prior diagnosis of osteonecrosis of the jaw
  • Patients previously treated with osteoclast inhibition therapy are eligible, provided the following criteria apply:
  • Prior osteoclast inhibition for low bone mass (osteoporosis or osteopenia):
  • Patients may have previously received at most 3 doses of osteoclast-inhibiting therapy with denosumab, IV ibandronate, pamidronate, or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration
  • Prior oral bisphosphonate therapy at osteoporosis or osteopenia dosing at any time prior to registration is allowed
  • Prior exposures to other medications used to treat low bone mass at osteoporosis or osteopenia dosing are permitted
  • Prior osteoclast inhibition for metastatic bone disease (tumor involving bone):
  • Patients may have previously received osteoclast-inhibiting therapy with denosumab, ibandronate (oral or IV cancer dosing), pamidronate, or zoledronic acid to treat metastatic bone disease within 180 days prior to registration
  • Patients receiving these regimens for metastatic bone disease prior to 180 days before registration are not eligible
  • Prior osteoclast-inhibiting therapy at higher dosing than outlined above at any time prior to registration is not allowed

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-3
  • Patients who may be acutely ill from spinal cord compromise, hypercalcemia of malignancy, or other process may be study candidates once the acute condition has been addressed and performance status improves to 0-3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Willing and physically able to comply with study procedures and assessments
  • Willing to provide information on personal history, including tobacco and alcohol use, and pain assessment
  • Willing to provide access to prior and future dental information
  • No other prior malignancy except for any of the following:
  • Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
  • In situ cervical cancer
  • Adequately treated stage I or II cancer for which the patient is currently in complete remission

  • Any other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer
  •  Concurrent participation in other therapeutic and non-therapeutic clinical trials allowed
  • The sum of prior IV bisphosphonate doses must not be greater than 10
  • The sum of prior denosumab doses must not be greater than 8
  • The total of both IV bisphosphonate and denosumab used for any indication must not be greater than 12 doses

OBJECTIVES:

Primary

  • To prospectively access the cumulative incidence of osteonecrosis of the jaw (ONJ) at 3 years in cancer patients with bone metastasis receiving zoledronic acid treatment.

Secondary

  • To describe the clinical presentation and natural history of ONJ.
  • To identify potential risk factors for the development of ONJ.
  • To estimate the cumulative incidence of ONJ at 3 years for different tumor types (i.e., breast cancer, multiple myeloma, prostate cancer, lung cancer, and other cancers).
  • To better define the patient-related outcomes of ONJ.

National Enrollment to Date: 3416/3500

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ECOG 1305: A Phase III Randomized Trial of Cisplatin and Docetaxel with or without Bevacizumab In Patients with Recurrent or Metastatic Head and Neck Cancer Treatment”

OUTLINE:
This is a multicenter study. Patients are stratified by performance status (0 vs. 1), weight loss (< 5% vs. ≥ 5% of total body weight in the past 6 months), prior radiotherapy to head and neck (yes vs. no), and chemotherapy regimen (cisplatin/docetaxel vs. cisplatin/fluorouracil). Patients are randomized to1 of 2 treatment arms.

  • Arm I (chemotherapy): Patients receive chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1 OR cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously over days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity*.

  • Arm II (chemotherapy and bevacizumab): Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment with chemotherapy and bevacizumab repeats every 21 days in the absence of disease progression or unacceptable toxicity*.

NOTE: *Treatment with chemotherapy may be discontinued if there is maximum response (i.e., no improvement in tumor measurements for 2 or more courses) after course 6; bevacizumab administration continues until disease progression in arm II.

After completion of study treatment, patients are followed every 3-6 months for 5 years.

ELIGIBILITY:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) from any primary site, including unknown primary cancers of the head and neck
  • No nasopharyngeal carcinoma of histologic types WHO 2 or 3
  • No squamous cell carcinoma that originated in the skin
  • Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
  • A second primary squamous cell carcinoma of the head and neck allowed if eligibility is based on a recurrent or metastatic first primary squamous cell carcinoma of the head and neck
  • Patients who refuse radical resection for recurrent disease are eligible
  • Patients must have measurable disease based on RECIST
  • Disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma after radiotherapy
  • Persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiotherapy (radiographic findings are acceptable providing that clear cut measurements can be made)
  • Patients must be progression-free for at least 6 months after completion of chemotherapy or chemoradiotherapy or radiotherapy plus cetuximab given as part of initial potential curative therapy (if received such prior therapy)
  • At least 6 months since completion of prior concurrent radiotherapy plus cetuximab (8 weeks for cetuximab given as part of adjuvant regimen post radiotherapy)
  • Patients having progression after 2 courses of induction chemotherapy are not eligible
  • No tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies (i.e., tumor crosses fat boundary)
  • No central (i.e., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies
  • No known brain metastases
  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3

  • Creatinine clearance ≥ 60 mL/min
  • Total bilirubin normal
  • AST or ALT and alkaline phosphatase must meet one of the following criteria:
  • Alkaline phosphatase normal AND AST or ALT ≤ 5 x upper limit of normal (ULN)
  • Alkaline phosphatase > 1 but ≤ 2.5 x ULN AND AST or ALT > 1 but ≤ 1.5 x ULN
  • Alkaline phosphatase > 2.5 but ≤ 5 x ULN AND AST or ALT normal
  • Urine protein: creatinine ratio ≤ 0.5 OR 24-hour urine protein < 1,000 mg
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patients who meet the following criteria are excluded:
  • Any prior history of bleeding related to the current head and neck cancer
  • History of gross hemoptysis (bright red blood of ½ teaspoon or more per episode of coughing) ≤ 3 months prior to enrollment
  • No history of coagulopathy or hemorrhagic disorders
  • No history of thrombosis (e.g., pulmonary embolism or deep venous thrombosis) currently requiring therapeutic anticoagulation (prophylactic use of warfarin 1 mg/day is allowed)
  • INR < 1.5 at registration
  • No hypercalcemia related to head and neck cancer
  • Patients with a prior history of squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated
  • Patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease free for 5 years post diagnosis
  • No current peripheral neuropathy ≥ grade 2
  • Patients must not have any co-existing condition that would preclude full compliance with the study
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 (if the physician's choice of chemotherapy is docetaxel)
  • Patients must have a blood pressure (BP) ≤ 150/90 within 2 weeks prior to randomization
  • Patients with a history of hypertension must be well-controlled upon study entry (BP ≤ 150/90 mm Hg) on a stable regimen of anti-hypertensive therapy
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration
  • No significant traumatic injury within the past 28 days
  • No serious non-healing wound, ulcer, or bone fracture
  • No unstable angina or myocardial infarction within the past 6 months
  • No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease
  • No history of aortic dissection or presence of aneurysm > 6 cm (or at high risk for rupture)
  • No serious cardiac arrhythmia requiring medication (history of chronic atrial fibrillation or other atrial arrhythmia with controlled rate on medication is allowed)
  • No clinically significant peripheral vascular disease manifested by intermittent claudication or need for vascular intervention
  • No history of any CNS cerebrovascular ischemia or stroke within the past 6 months
  • No active serious infection
  • No history of a serious human anti-human antibody (HAHA) reaction
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible
  • Chronic latex xerostomia, speech and swallowing abnormalities, resulting from prior radiation or surgery, allowed provided nutritional status is stable
  • No other prior malignancy except curatively treated squamous cell or basal carcinoma of the skin, in situ cervical cancer, or malignancy for which the patient has been curatively treated and remains disease-free for the past 3 years

  • No concurrent bisphosphonates for bone metastasis unless initiated > 3 months before study entry

  • Patients must have recovered to grade 1 or better from the effects of any prior surgery, chemotherapy, or radiotherapy AND > 4 weeks post-surgery
  • No more than one prior radiotherapy regimen, curative or palliative, to the head and neck allowed
  • At least 4 months since prior radiotherapy in combination with chemotherapy and/or cetuximab
  • At least 8 weeks since prior radiotherapy given alone
  • At least 3 weeks since prior radiotherapy to other areas
  • No prior bevacizumab
  • No prior chemotherapy or biologic/molecular-targeted therapy for recurrent or metastatic SCCHN
  • Patients may have received one regimen of induction, concurrent chemoradiotherapy, and/or adjuvant chemotherapy as part of initial potential curative therapy
  • A minimum of 6 months is required between last dose of chemotherapy or chemoradiotherapy and study treatment
  • No major surgical procedure or open biopsy within 28 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study
  • More than 4 weeks since prior surgery
  • No other concurrent investigational agent
  • Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function
  • The use of anti-platelet agents (e.g., dipyridamole [Persantine], ticlopidine [Ticlid], or clopidogrel [Plavix]) is allowed only if patient is not receiving aspirin or NSAIDs known to inhibit platelet function
  • No HIV-positive patients on combination antiretroviral therapy
  • No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications
  • No concurrent amifostine

OBJECTIVES:

Primary:

I. To compare the overall survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with standard cisplatin-based chemotherapy with or without bevacizumab.

Secondary:

I. To assess toxicities with the addition of bevacizumab to each cisplatin-doublet (cisplatin/docetaxel and cisplatin/fluorouracil).

II. To compare the objective response rates and the progression-free survival achieved with the above therapies.

National Enrollment to Date: 310/400

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NCCTG N107C: “A Phase III Trial of Post-Surgical Stereotactic Radiosurgery Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease”

Outline:

This is a multicenter study. Patients are stratified according to age in years (< 60 vs. ≥ 60), extracranial disease controlled (≤ 3 months vs. > 3 months), number of pre-operative brain metastases (1 vs. 2-4), histology (lung vs. radioresistant [brain metastases from a sarcoma, melanoma, or renal cell carcinoma histology] vs. other), and resection cavity maximal diameter (≤ 3 cm vs. > 3 cm). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole-brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks.

  • Arm II: Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure.

-Serum, whole blood, and urine samples are collected at baseline and periodically during study for genetic markers, inflammatory markers, oxidative stress biomarkers, and hormone and growth factor studies by ELISA and other assays.

-Patients complete the Functional Assessment of Cancer Therapy-Brain (FACT-BR), the activities of daily living (ADLs), the Fatigue/Uniscale Assessment, and the Linear Analog Self Assessment (LASA) quality-of-life questionnaires at baseline and periodically during study. Neurocognitive functions, such as memory, verbal fluency, visual attention, executive function, and delayed memory, are also assessed.

After completion of study therapy, patients are followed up periodically for 5 years.

ELIGIBILITY:

Disease Characteristics:

  • Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions

  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site
    • Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site
       
  • Any unresected lesions must measure ≤ 3.0 cm in maximal extent on the contrasted MRI brain scan obtained ≤ 35 days prior to pre-registration
    • The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastases only surgical cavity size determines eligibility
       
  • Post-operative MRI confirmed zero, one, two or three unresected lesions
    • Each unresected lesion must measure ≤ 3.0 cm in maximal extent on the contrasted post-operative MRI brain scan

    • The pre-registration, post-operative, brain scan may be used for the randomization scan if obtained ≤ 28 days prior to randomization
      • Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior to randomization
         
  • Resection cavity must measure < 5.0 cm in maximal extent on the post-operative MRI (or CT) brain scan obtained ≤ 35 days prior to pre-registration
    • The pre-registration, post-operative brain scan may be used for the planning scan if obtained ≤ 28 days prior to randomization
      • Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior to randomization
         
    • It is permissible for the resection of a dominant brain metastasis to include a smaller “satellite” metastasis as long as the single resection cavity is less than the maximum size requirements
       
  • All standard tumor-staging procedures necessary to define baseline extracranial disease status completed ≤ 42 days prior to pre-registration
  • No primary germ cell tumor, small cell carcinoma, or lymphoma

  • No widespread definitive leptomeningeal metastasis

  • No brain metastasis that is located ≤ 5 mm of the optic chiasm or within the brainstem

Prior/Concurrent Therapy:

  • No prior cranial radiotherapy

  • No planned cytotoxic chemotherapy during the stereotactic radiosurgery (SRS) or whole-brain radiotherapy (WBRT)

  • Concurrent hormonal agents, steroids, and/or anticonvulsants allowed

Patient Characteristics:

  • ECOG performance status (PS) 0, 1, or 2

  • Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system

  • Willing and able to complete neurocognitive examination without assistance

  • Willing and able to complete quality-of-life (QOL) questionnaires by themselves or with assistance

  • Willing to provide mandatory blood and urine samples for correlative research purposes

  • None of the following:
    • Pregnant or nursing

    • Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment
       
  • Able to complete a MRI with contrast of the head

  • No known allergy to gadolinium

OBJECTIVES:

Primary

  1. To ascertain in patients with one to four brain metastases whether there is improved overall survival in patients who receive stereotactic radiosurgery (SRS) to the surgical bed compared to patients who receive whole-brain radiotherapy (WBRT).

  2. To ascertain in patients with one to four brain metastases whether there is less neurocognitive progression at 6 months post-radiation in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

Secondary

  1. To ascertain in patients with resected brain metastases whether there is improved quality-of-life (QOL) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

  2. To ascertain in patients with one to four brain metastases whether there is equal longer time to central nervous system (CNS) failure (brain) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

  3. To ascertain in patients with one to four brain metastases whether there is longer duration of functional independence in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

  4. To ascertain in patients with one to four brain metastases whether there is better long-term neurocognitive status in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

  5. To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

  6. To evaluate local tumor bed recurrence at 6 months with post-surgical SRS to the surgical bed in comparison to WBRT.

  7. To evaluate time to local recurrence with post-surgical SRS to the surgical bed in comparison to WBRT.

  8. To evaluate if there is any difference in CNS failure patterns (local, distant, leptomeningeal) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

Exploratory

  1. To evaluate radiation changes in the limbic system that may correlate with neurotoxicity using brain MRI scans.

  2. To determine whether Apo E (i.e., Apo E2, Apo E3, and Apo E4) genotyping may prove to be a predictor of radiation-induced neurocognitive decline (or neuroprotection).

  3. To determine whether inflammatory markers (i.e., IL-1, IL-6, and TNF-α) may prove to be predictors of radiation-induced neurocognitive decline.

  4. To determine whether oxidative stress biomarkers (i.e., protein carbonyl content, lipid hydroperoxides, and isoprostane levels) may prove to be predictors of radiation-induced neurocognitive decline.

  5. To determine whether hormone and growth factors [i.e., glucocorticoids (e.g., cortisol), gonadal steroids (e.g., estradiol, testosterone, progesterone), growth hormone, human chorionic gonadotropin (hCG), insulin-like growth factor-1 (IGF-1), and neuronal growth factor (NGF)] may prove to be a predictor of radiation-induced neurocognitive decline.

National Enrollment to Date: 95/192

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