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

Phase 1
18 Years
Not Enrolling
Breast Cancer, Kidney Cancer, Lymphoma, Melanoma, Multiple Myeloma, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


- 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.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

- At least 4 months since prior interferon therapy and/or ≤ 400 million units of

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ernest C. Borden, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

January 2001

Completion Date:

January 2004

Related Keywords:

  • Breast Cancer
  • Kidney Cancer
  • Lymphoma
  • Melanoma
  • Multiple Myeloma
  • Sarcoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV melanoma
  • unspecified adult solid tumor, protocol specific
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Lymphoma
  • Melanoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasms
  • Sarcoma



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195