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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00276536
• Date of registration: 12/01/2006
• Primary sponsor: The Cleveland Clinic
• Public title: Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma IFNa
• Scientific title: Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
• Date of first enrolment: January 2001
• Target sample size: 35
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00276536
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ernest C. Borden, MD
• Affiliation: The Cleveland Clinic

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Kidney Cancer

Lymphoma

Melanoma

Multiple Myeloma

Sarcoma

Unspecified Adult Solid Tumor, Protocol Specific

Intervention(s)

Biological: recombinant interferon alpha-1b

Drug: IFN

Primary Outcome(s)

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]

Secondary ID(s)

CASE-CCF-3575

P30CA043703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)