RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Filgrastim and stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by therapy used to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 and stem cell factor following peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma, Hodgkin's disease, or advanced breast cancer.

Condition	Treatment or Intervention	Phase
Lymphoma Breast Cancer	Drug: filgrastim  Drug: interleukin-2  Drug: interleukin-2/stem cell factor  Drug: stem cell factor	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the safety and maximum tolerated dose of interleukin-2 (IL-2) and stem cell factor (SCF) following autologous peripheral blood stem cell transplantation in patients with non-Hodgkin's lymphoma or advanced breast cancer.

II. Determine the effectiveness of filgrastim (G-CSF) and SCF as mobilizing agents in these patients.

PROTOCOL OUTLINE: This is a dose escalation study of stem cell factor (SCF).

Patients receive filgrastim (G-CSF) subcutaneously (SC) followed by SCF SC daily for 7-10 days. Beginning on the fifth day of G-CSF and SCF injections, peripheral blood stem cells (PBSC) are collected over several days. PBSC are later reinfused and patients receive G-CSF SC daily until hematopoietic recovery. At least 30 days but no later than 110 days following transplant, patients who did not experience adverse reactions to SCF during mobilization begin posttransplant immunotherapy. Patients receive interleukin-2 SC daily and SCF SC 3 times weekly for 6 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of SCF during posttransplant immunotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.

Patients are followed at 1 week, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study within 1-1.5 years.

Ages Eligible for Study:  18 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Hodgkin's disease, non-Hodgkin's lymphoma, or advanced stage breast cancer; Planned treatment is autologous peripheral blood stem cell transplantation; No T-cell lymphomas
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; At least 1 week since prior hematopoietic growth factors
• Chemotherapy: Not specified
• Endocrine therapy: No concurrent steroids
• Radiotherapy: No concurrent radiotherapy
• Surgery: Not specified
• Other: No concurrent beta adrenergic blocking agents; No concurrent therapeutic antibiotics posttransplant; No concurrent IV hyperalimentation or IV fluids posttransplant

--Patient Characteristics--

• Age: 18 to 65
• Menopausal status: Not specified
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Immunologic: No history of seasonal or recurrent asthma within the past 5 years; No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection; No anaphylactic/anaphylactoid type event manifested by disseminated urticaria, laryngeal edema, hypotension, and/or bronchospasm (e.g., food or insect venom) within the past 5 years; Drug allergies manifested solely by rash allowed; No history of angioedema or recurrent urticaria lasting longer than 14 days; No history of hereditary or acquired angioedema; No known allergy to E. coli derived products
• Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception

Study chairs or principal investigators

Linda Jean Burns,  Study Chair,  University of Minnesota Cancer Center   

Study ID Numbers:  CDR0000067982; UMN-MT-9821; NCI-G00-1803
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005993
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08