Status:
COMPLETED
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in tr...
Detailed Description
OBJECTIVES: * Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma. * Determine the maximum tolerated dose (MTD) of IFN-α1b given ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy, including, but not limited to, renal cell carcinoma, melanoma, Kaposi's sarcoma, breast carcinoma, lymphoma, myeloma, or tumors of endothelial origin
- Stage IV disease
- Refractory to standard therapy
- Measurable or evaluable disease
- Evaluable disease can include clinically or radiographically nonmeasurable tumor or specific tumor markers
- Patients with prior solitary CNS metastasis allowed
- Must have had prior definitive therapy ≥ 3 months previously
- No requirement for glucocorticoids unless for physiologic replacement
- No multiple CNS metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.3 times upper limit of normal (ULN) OR
- Creatinine clearance of 60 mL/min
- Bilirubin ≤ 1.3 times ULN
- AST ≤ 5 times ULN
- No pregnant or lactating women
- Fertile women and men, unless surgically sterile, must use effective contraception
- No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
- No congestive heart failure
- No angina pectoris
- No New York Heart Association class III or IV disease
- No other severe cardiovascular disease
- No known seizure disorder
- No known HIV or hepatitis B surface antigen positivity
- No active clinical infection requiring antibiotics within the past 7 days
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 months since prior interferon therapy and/or ≤ 400 million units of interferon
- At least 3 weeks since prior major surgery requiring general anesthesia
- At least 3 weeks since prior radiotherapy or chemotherapy
- Treatment with hormones or other chemotherapeutic agents may not be administered except for steroids given for preexisting adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
- No prior organ allograft
- No concurrent dexamethasone, other steroidal antiemetics, or anti-inflammatories
- No concurrent palliative radiotherapy
Exclusion
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00276536
Start Date
January 1 2001
End Date
January 1 2004
Last Update
October 14 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195-5044