Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma

Overview

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.

Full Title of Study: “Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: January 2004

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

• Biological: recombinant interferon alpha-1b
  • interferon
• Drug: IFN
  • IFN daily

Arms, Groups and Cohorts

• Experimental: Treatment
  • IFN weekly

Clinical Trial Outcome Measures

Primary Measures

• 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
  • Time Frame: 3 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • The Cleveland Clinic
• Collaborator
  • National Cancer Institute (NCI)
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Ernest C. Borden, MD, Study Chair, The Cleveland Clinic