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Completed

NCT Number: NCT00276536

Interferon Alfa in Treating Patients With Stage IV 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant interferon alpha-1b

Biological

interferon

Other names: Interferon

IFN

Drug

IFN daily

Other names: Interferon

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: IFNa

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Jan 13, 2006
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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