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| Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005993 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Lymphoma |
Drug: aldesleukin Drug: filgrastim Drug: recombinant human stem cell factor Procedure: peripheral blood stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Immunotherapy With Subcutaneous Il-2 and Stem Cell Factor (SCF) for Patients With Lymphoma or Breast Cancer After Autologous Transplantation |
| Study Completion Date: | July 2005 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
| Study ID Numbers: | CDR0000067982, UMN-MT-9821, NCI-G00-1803 |
| Study First Received: | July 5, 2000 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005993 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Anti-Retroviral Agents Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Leukemia, B-cell, Chronic Hodgkin Disease |
Lymphoma Breast Diseases Lymphoma, Large B-Cell, Diffuse Anti-HIV Agents Immunoproliferative Disorders Skin Diseases Hodgkin Lymphoma, Adult Breast Neoplasms Hodgkin's Disease Antiviral Agents Recurrence Burkitt's Lymphoma Lymphatic Diseases Chronic Lymphocytic Leukemia Aldesleukin |
|
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Immunoproliferative Disorders Skin Diseases Immune System Diseases Antineoplastic Agents Breast Neoplasms Antiviral Agents Pharmacologic Actions Lymphatic Diseases |
Neoplasms Aldesleukin Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Breast Diseases |
