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

NeuroTherapia, Inc.

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Sarcoma

Multiple Myeloma

Melanoma

Unspecified Adult Solid Tumor, Protocol Specific

Kidney Cancer

Lymphoma

Treatments

Biological: recombinant interferon alpha-1b

Drug: IFN

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00276536

CASE-CCF-3575 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 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.

Enrollment

35 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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