Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Cancer and Leukemia Group B.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00074035
First received: December 10, 2003
Last updated: June 21, 2011
Last verified: June 2011

December 10, 2003
June 21, 2011
December 2003
August 2008   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Both complete and partial response will be assessed
Not Provided
Complete list of historical versions of study NCT00074035 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: During tx, then at relapse or progression ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: At 1 year and 2 years post treatment initiation ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: At initiation of Tx and at 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease

RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.

PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.

OBJECTIVES:

Primary

  • Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin.

Secondary

  • Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the infection rate in patients treated with this drug.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the changes in lymphocyte populations in patients treated with this drug.
  • Determine the survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.

Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
Drug: pentostatin
4 mg/sq m IV infusion over 20-30 min q 2 weeks
Experimental: Pentostatin
treatment of pts with refractory graft vs host disease
Intervention: Drug: pentostatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
39
March 2013
August 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed chronic graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion

    • Progressive, quiescent, or de novo onset
  • Extensive stage disease requiring systemic immunosuppressive therapy, defined according to Seattle criteria as 1 of the following:

    • Generalized skin involvement
    • Limited skin involvement or hepatic involvement with any of the following:

      • Liver histology showing chronic progressive hepatitis, bridging necrosis, or cirrhosis
      • Eye involvement (i.e., Schirmer's test with less than 5 mm wetting)
      • Involvement of minor salivary glands or oral mucosa
      • Involvement of any other organ
  • Failed prior corticosteroid therapy, meeting 1 of the following criteria:

    • Progressive disease or less than a minor response in any organ system despite 2 weeks on steroid therapy at a dose of at least 1 mg/kg of methylprednisolone or equivalent
    • No response or minor response after at least 4 weeks of steroid therapy at a dose of least 0.5 mg/kg of methylprednisolone or equivalent
    • Less than a partial response after 8 weeks of steroid therapy at a dose of least 0.5 mg/kg of methylprednisolone or equivalent
    • Required a dose of least 0.5 mg/kg of methylprednisolone or equivalent after completion of at least 12 weeks of corticosteroid therapy in order to maintain a partial response or better
    • Required a dose of least 10 mg/kg of methylprednisolone or equivalent after completion of at least 18 weeks of corticosteroid therapy in order to maintain a partial response or better
    • Progressive extensive stage chronic GVHD after completion of at least 18 weeks of corticosteroid therapy and currently requiring reintroduction of corticosteroid therapy at a dose of least 10 mg/kg of methylprednisolone or equivalent OR an additional therapy (e.g., photopheresis or psoralen-ultraviolet-light [PUVA] therapy)
  • Established chronic GVHD either not improving or progressing on other immunosuppressive agents allowed provided steroid refractoriness has been previously established

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 50,000/mm^3 (without transfusion)

Hepatic

  • Not specified

Renal

  • Creatinine clearance at least 30 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • See Disease Characteristics
  • No concurrent corticosteroids as antiemetics

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Concurrent continuation of other immunosuppressants administered during onset or progression of chronic GVHD is allowed
  • No concurrent mechanical ventilation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074035
CDR0000341678, U10CA031946, CALGB-100101, ECOG-1010
No
Monica M Bertagnolli, MD, Cancer and Leukemia Group B
Cancer and Leukemia Group B
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
Study Chair: Sherif S. Farag, MD, PhD Ohio State University
Cancer and Leukemia Group B
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP