Trial record 17 of 62 for:
"Systemic mastocytosis"
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire d'Amiens
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00769587
First received: October 8, 2008
Last updated: May 12, 2011
Last verified: July 2009
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Purpose
RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease.
PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Nonneoplastic Condition Precancerous Condition |
Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Study of Thalidomide in Mastocytosis |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective reduction of the infiltration rate at 6 months [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.
Secondary
- Determine the tolerability of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of systemic mastocytosis
- Aggressive or borderline (smoldering) disease (in first line or more)
- Relapsed or progressive disease
- Measurable or evaluable disease
- Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs
- No nonsymptomatic mastocytosis
PATIENT CHARACTERISTICS:
- Life expectancy > 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment
- Bilirubin < 2 times normal (unrelated to disease)
- Liver enzymes < 2 times normal (unrelated to disease)
- Creatinine ≤ 300 mmol/L
- No central or peripheral neuropathy leading to psychiatric concerns
- No HIV positivity
- No active infection or other serious underlying illness that would preclude treatment
- No history of thromboembolism or deep vein thrombosis
- No geographical, social, or psychological reasons preventing medical monitoring
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy)
- No other concurrent treatment specific for this disease
- No concurrent participation in another experimental drug trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769587
Locations
| France | |
| Centre Hospitalier Universitaire d'Amiens | |
| Amiens, France, 80054 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire d'Amiens
Investigators
| Study Chair: | Gandhi Damaj | Centre Hospitalier Universitaire d'Amiens |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00769587 History of Changes |
| Other Study ID Numbers: | CDR0000599564, CHU-AMIENS-PI06, EUDRACT-2006-005087-10, INCA-RECF0510 |
| Study First Received: | October 8, 2008 |
| Last Updated: | May 12, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
aggressive systemic mastocytosis smoldering systemic mastocytosis |
Additional relevant MeSH terms:
|
Mastocytosis Urticaria Pigmentosa Mastocytoma Precancerous Conditions Mastocytosis, Systemic Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Skin Diseases Mastocytosis, Cutaneous Pigmentation Disorders Thalidomide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013