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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00132015 |
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with systemic mastocytosis.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multicentric Castleman Disease Precancerous/Nonmalignant Condition |
Drug: tanespimycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Clinical Trial of 17-(Allylamino)-17- Demethoxygeldanamycin (17-AAG, NSC 330507 and EPL Diluent, NSC 704057) in Adults With Systemic Mastocytosis |
Estimated Enrollment: | 37 |
Study Start Date: | May 2006 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients achieving a partial response receive at least 4 additional courses beyond their maximum response. Selected patients may receive additional courses of therapy beyond the protocol guidelines at the discretion of the principal investigator.
Quality of life is assessed at baseline and before each treatment course.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 10-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed systemic mastocytosis
Objective evidence of disease, as defined by the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No symptomatic pulmonary disease requiring medication including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent complimentary or alternative medications* including, but not limited to, the following:
United States, Maryland | |
NCI - Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Antonio T. Fojo, MD, PhD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000438778, NCI-06-C-0076, NCI-6454, NCI-P6175 |
Study First Received: | August 16, 2005 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00132015 |
Health Authority: | United States: Food and Drug Administration |
Waldenstrom macroglobulinemia multicentric Castleman disease unicentric Castleman disease adult grade III lymphomatoid granulomatosis polycythemia vera essential thrombocythemia hairy cell leukemia monoclonal gammopathy of undetermined significance adult Burkitt lymphoma adult diffuse large cell lymphoma adult diffuse mixed cell lymphoma |
adult diffuse small cleaved cell lymphoma adult immunoblastic large cell lymphoma adult lymphoblastic lymphoma grade 1 follicular lymphoma grade 2 follicular lymphoma grade 3 follicular lymphoma mantle cell lymphoma marginal zone lymphoma small lymphocytic lymphoma precancerous/nonmalignant condition |
Polycythemia Giant Lymph Node Hyperplasia Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Mast cell disease Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Neoplasms, Connective and Soft Tissue Leukemia, Lymphocytic, Chronic, B-Cell Hemorrhagic thrombocythemia Thrombocythemia, Hemorrhagic Chronic lymphocytic leukemia Essential thrombocytosis Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Hematologic Diseases Leukemia, B-cell, chronic Myeloproliferative Disorders Waldenstrom Macroglobulinemia Mastocytosis Lymphoma, Non-Hodgkin Hairy cell leukemia Multi-centric Castleman’s Disease Monoclonal gammopathy of undetermined significance Precancerous Conditions Lymphoma, Follicular Lymphoma, large-cell Burkitt's lymphoma Leukemia Lymphoma, Large-Cell, Immunoblastic |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Neoplasms, Connective Tissue |