Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

August 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003887 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation

Official Title ^ICMJE

Donor Lymphocyte Infusion (DLI) as Adoptive Immunotherapy for Relapse Malignancies After Allogeneic Hematopoietic Transplantation

Brief Summary

RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer that has recurred following bone marrow or peripheral stem cell transplantation.

PURPOSE: Phase II trial to study the effectiveness of donated white blood cells in treating patients who have relapsed cancer following transplantation of donated bone marrow or peripheral stem cells.

Detailed Description

OBJECTIVES: I. Offer donor lymphocyte infusion as adoptive immunotherapy in patients with relapsed malignancies after allogeneic bone marrow or peripheral blood stem cell transplantation and who are not eligible for other FHCRC protocols.

OUTLINE: Patients with rapidly progressive disease receive reinduction chemotherapy and radiotherapy prior to study therapy. Donor lymphocyte infusions (DLI) begin after recovery from chemotherapy or sooner, if clinically indicated. Patients receive 1 or more DLI from the original donor. Patients are followed monthly for 3 months, then every 3-6 months for 9 months.

PROJECTED ACCRUAL: An unlimited number of patients will be accrued for this study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Breast Cancer
Chronic Myeloproliferative Disorders
Gestational Trophoblastic Tumor
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Neuroblastoma
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor

Intervention ^ICMJE

Biological: peripheral blood lymphocyte therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS: Diagnosis of relapsed malignancy after allogeneic transplantation Rapidly progressive malignancies (acute leukemias) should receive induction chemotherapy or radiotherapy prior to this study Persistent donor cells Must be able to tolerate a taper of steroids to a dosage of no greater than 0.25 mg/kg/day and be off all other immunosuppressive therapy for 2 weeks without significant flare of graft vs host disease (GVHD) No grade II-IV acute GVHD or extensive chronic GVHD Same donor as for prior transplant

PATIENT CHARACTERISTICS: Age: 1 to 70 Performance status: Karnofsky 30-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics At least 1 week since immunosuppressive therapy for advanced malignancy At least 2 weeks since immunosuppressive therapy for nonadvanced malignancy Radiotherapy: See Disease Characteristics Surgery: Not specified

Gender

Both

Ages

1 Year to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00003887

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067056, FHCRC-600.03, NCI-H99-0031

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Mary E. D. Flowers, MD

Fred Hutchinson Cancer Research Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2007

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