Symptoms and General Pathology

All Conditions

Neoplasms

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Blood and Lymph Conditions

Immune System Diseases

Infections

Rare Diseases

Recurrence

Breast Neoplasms

Lymphoma, Large B-Cell, Diffuse

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma

Lymphoma, Non-Hodgkin

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

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Lymphoma, B-Cell

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Neoplasms by Histologic Type

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Immunoproliferative Disorders

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B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

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Marginal Zone Lymphoma

Hodgkin Lymphoma

Lymphoma, Large-cell, Immunoblastic

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Aldesleukin

Immunomodulating Agents

Lenograstim

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

aldesleukin

filgrastim

recombinant human stem cell factor

peripheral blood stem cell transplantation

Linda J. Burns, MD

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.

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.

Biological Therapies Following Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Advanced Breast Cancer

Immunotherapy With Subcutaneous Il-2 and Stem Cell Factor (SCF) for Patients With Lymphoma or Breast Cancer After Autologous Transplantation

National Cancer Institute (NCI)

Masonic Cancer Center, University of Minnesota

Hypersensitivity

Analgesics

Antirheumatic Agents

Etoposide

Cytarabine

Mitoxantrone

Paclitaxel

Cyclophosphamide

Albumin-Bound Paclitaxel

Melphalan

Etoposide phosphate

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Antimetabolites

cyclophosphamide

cytarabine

etoposide

melphalan

mitoxantrone hydrochloride

paclitaxel

Russell J. Schilder, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine how many patients with chemotherapy sensitive relapsed non-Hodgkin's lymphoma receiving sequential high dose chemotherapy achieve a collection of a minimum 5 million CD34+ cells/kg in one large volume apheresis. II. Determine the feasibility and safety of this regimen in these patients. III. Determine disease free and overall survival of patients receiving this regimen.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24 hours on day 1. Filgrastim (G-CSF) and stem cell factor (SCF) are administered subcutaneously beginning on day 3 for approximately 7-14 days (until the completion of leukapheresis). Peripheral blood stem cells (PBSC) are collected over 3-5 days. Three weeks after leukapheresis is completed, patients receive cytarabine IV over 2 hours twice a day on days -6 to -3. Mitoxantrone IV is administered over 1 hour on day -6. CD34+ PBSC are reinfused on day 0. Four weeks later, patients receive etoposide IV over 11 hours on day -2 and melphalan IV over 30 minutes twice on day -1. CD34+ PBSC are reinfused on day 0. Concurrent G-CSF is administered subcutaneously and continues until blood counts recover. Patients are followed at 4 weeks, every 3 months for the first 2 years, and then every 6 months for the next 2 years.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkin's Lymphoma

Fox Chase Cancer Center

Russell Schilder, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Biological Therapies Following Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Advanced Breast Cancer	NCT00005993	Breast Cancer Lymphoma	aldesleukin filgrastim recombinant hum... peripheral bloo...	18 Years - 65 Years	Masonic Cancer Center, University of Minnesota
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma	NCT00003957	Lymphoma	filgrastim recombinant hum... cyclophosphamid... cytarabine etoposide melphalan mitoxantrone hy... paclitaxel peripheral bloo...	18 Years -	Fox Chase Cancer Center

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