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| Sponsored by: |
Cancer Treatment Centers of America |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003408 |
Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and peripheral stem cell transplantation with biological therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy with sargramostim, interleukin-2, and interferon alfa following chemotherapy and peripheral stem cell transplantation in treating patients who have cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor |
Biological: aldesleukin Biological: recombinant interferon alfa Biological: sargramostim |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 1998 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of interleukin-2 and interferon alfa.
Beginning 14 days after the autologous stem cell transplant, patients receive daily subcutaneous injections of sargramostim (GM-CSF) on days 1-7 and daily intravenous interleukin-2 on days 3-7, followed by 1 week of rest.
Patients then receive a subcutaneous injection of interferon alfa three times a week for 3 weeks followed by one more week of rest. Treatment is repeated for four courses.
Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa until a maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 10 patients experience dose limiting toxicity. Intrapatient dose escalation occurs in courses 2-4, in the absence of dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following cancers and undergoing high dose chemotherapy with autologous stem cell rescue (ASCR):
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| Midwestern Regional Medical Center | |
| Zion, Illinois, United States, 60099 | |
| Study Chair: | Anastasios Raptis, MD | Cancer Treatment Centers of America |
More Information
| Study ID Numbers: | CDR0000066418, MRMC-CTCA-9801, NCI-V98-1449 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003408 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma refractory multiple myeloma recurrent childhood rhabdomyosarcoma stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer disseminated neuroblastoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors stage I multiple myeloma stage II multiple myeloma |
stage III multiple myeloma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia |
|
Anti-Infective Agents Blast Crisis Seminoma Mantle Cell Lymphoma Urogenital Neoplasms Preleukemia Hemorrhagic Disorders Wilms' Tumor Neoplasm Metastasis Neuroepithelioma Ovarian Cancer Kidney Diseases Rhabdomyosarcoma Endocrine Gland Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Testicular Cancer Hematologic Diseases Blood Coagulation Disorders Genital Neoplasms, Female Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Carcinoma Aldesleukin Leukemia, Myeloid, Accelerated Phase Sarcoma Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Immunologic Factors |
|
Anti-Infective Agents Neuroectodermal Tumors, Primitive Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Preleukemia Pathologic Processes Neoplasms by Site Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Kidney Diseases Breast Diseases Endocrine Gland Neoplasms |
Anti-HIV Agents Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Genital Neoplasms, Female Myeloproliferative Disorders Endocrine System Diseases Breast Neoplasms Carcinoma Multiple Myeloma Neuroectodermal Tumors Neoplasms Aldesleukin Gestational Trophoblastic Neoplasms Interferon Alfa-2a |
