interferon alfa in treating patients with stage iv solid tumors, lymphoma, or myeloma

Conditions: Breast Cancer; Kidney Cancer; Lymphoma; Melanoma; Multiple Myeloma; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility 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

Keywords: stage iv melanoma unspecified adult solid tumor, protocol specific