Breast Cancer, Kidney Cancer, Lymphoma, Melanoma, Multiple Myeloma, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
stage IV melanoma, unspecified adult solid tumor, protocol specific
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 treating patients with stage IV solid tumors, lymphoma, or myeloma.
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 daily by subcutaneous injection in these patients. OUTLINE: This is a dose-escalation study. Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventions
BIOLOGICALrecombinant interferon alpha-1b
interferon
DRUGIFN
IFN daily
Sponsors
National Cancer Institute (NCI)
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course | 3 years |
Countries
United States
Outcome results
None listed