Clinical trial NCT00005993: Biological Therapies Following Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Advanced Breast Cancer
Official title: Immunotherapy With Subcutaneous Il-2 and Stem Cell Factor (SCF) for Patients With Lymphoma or Breast Cancer After Autologous Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Lymphoma
Keywords: stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent adult Hodgkin lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Eligibility 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

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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Linda J. Burns, MD
role: STUDY_CHAIR
References: