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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004916 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of ifosfamide, teniposide, and paclitaxel in treating patients who have relapsed non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: ifosfamide Drug: paclitaxel Drug: teniposide Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of teniposide. Patients are stratified according to whether they proceed to stem cell transplant or not.
Patients receive ifosfamide IV over 1-2 hours on days 1-3 every 3 weeks, teniposide IV over 2 hours on day 1 every 3 weeks, and paclitaxel IV over 1 hour weekly. Patients who are not candidates for stem cell transplant continue treatment for 120 days in the absence of disease progression or unacceptable toxicity. Patients proceeding to stem cell transplant continue treatment for 36 days. Peripheral blood stem cells (PBSC) may be harvested at this time if autologous transplant is planned. Transplant patients may then continue with chemotherapy or proceed to autologous or allogeneic PBSC transplant.
Cohorts of 3-5 patients receive escalating doses of teniposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 5 patients experience dose limiting toxicities.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma
Progressive disease following doxorubicin based chemotherapy
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 |
Study Chair: | Leo I. Gordon, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067597, NU-98H2, NCI-G00-1711 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004916 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 3 follicular lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult Burkitt lymphoma |
Lymphoma, Follicular Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Lymphoma Alkylating Agents Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antimitotic Agents Recurrence Teniposide |
Lymphatic Diseases Burkitt's Lymphoma Ifosfamide Paclitaxel Burkitt Lymphoma Mechlorethamine Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Mesna Isophosphamide mustard |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Pharmacologic Actions Teniposide Lymphatic Diseases Neoplasms |
Ifosfamide Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Lymphoma Alkylating Agents Nucleic Acid Synthesis Inhibitors Isophosphamide mustard |