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



Status:Completed
Conditions:Breast Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Hematology, Kidney Cancer
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 120
Updated:4/21/2016
Start Date:January 2001
End Date:January 2004

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Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma

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.

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
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