Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

This study has been completed.
Sponsor:
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
  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)
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Amiens
Investigators
Study Chair: Gandhi Damaj Centre Hospitalier Universitaire, 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
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 August 18, 2014