Completed

NCT Number: NCT00003408

Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Blast Crisis Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Burkitt Lymphoma Carcinogenesis Carcinoma Carcinoma, Embryonal Carcinoma, Ovarian Epithelial Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Chronic Myeloproliferative Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Endodermal Sinus Tumor Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Germinoma Gestational Trophoblastic Disease Gestational Trophoblastic Tumor Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Kidney Cancer Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Mesonephroma Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplastic Processes Neoplastic Syndromes, Hereditary Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Pregnancy Complications Pregnancy Complications, Neoplastic Primary Myelofibrosis Recurrence Sarcoma Seminoma Sezary Syndrome Skin Diseases Skin and Connective Tissue Diseases Teratoma Teratoma, Testicular Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Trophoblastic Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases Virus Diseases Wilms Tumor

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

About this study

OBJECTIVES:

Determine the feasibility of therapy with sargramostim (GM-CSF), interleukin-2 and interferon alfa following high dose chemotherapy and autologous stem cell rescue in patients with high risk cancer.
Determine the effect of this regimen on long-term leukocyte and platelet recovery following high dose chemotherapy and stem cell rescue in these patients.
Determine the cellular response to this regimen in these patients.
Assess progression free and overall survival rates in these patients.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

Diagnosis of one of the following cancers and undergoing high dose chemotherapy with autologous stem cell rescue (ASCR):

Metastatic breast cancer
Multiple myeloma
Hodgkin's disease
Recurrent or refractory low, intermediate, or high grade non-Hodgkin's lymphoma
Acute myelogenous leukemia beyond first remission
Acute lymphoblastic leukemia beyond first remission
Ovarian cancer
Refractory malignancy and measurable or evaluable disease (at time of ASCR)
Hormone receptor status:

Not specified
A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

Not specified

Menopausal status:

Not specified

Performance status:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Treatment and study plan

aldesleukin

Biological

recombinant interferon alfa

Biological

sargramostim

Biological

Sponsors and collaborators

Lead sponsor

Cancer Treatment Centers of America

Other

Registry information

Official study title

Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation

Important dates

Study start: 1998
Study completion: 2000
First posted: May 23, 2003
Registry last updated: Mar 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed