Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Allogeneic Mixed Chimerism Peripheral Blood Stem Cell Transplantation Utilizing In Vivo and In Vitro Alemtuzumab (Monoclonal Antibody CD52; Campath-1H) in Patients With High-Risk Hematologic Malignancies or Refractory Breast or Renal Cell Cancer or Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	DUMC-1340-99-7 NCI-G99-1617, NCT00004143

Trial Description

Purpose:

Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body’s normal cells. Giving a monoclonal antibody, alemtuzumab, at the time of transplant may stop this from happening.

This phase II trial is studying peripheral stem cell transplant and monoclonal antibody therapy to see how well they work in treating patients with high-risk hematologic cancer, refractory breast or kidney cancer, or melanoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Available brother or sister donor
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive infusions of alemtuzumab for 5 days followed by infusions of fludarabine and cyclophosphamide for 4 days. On days 7 and 8 patients will receive infusions of donated peripheral stem cells and alemtuzumab. They will then receive injections of filgrastim beginning on day 8 and continuing until blood counts return to normal. Patients will receive follow-up evaluations once a day for 2 months, twice a week for 6 weeks, every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

David Rizzieri, MD, Protocol chair		Ph: 919-668-1040

Registry Information
Official Title		Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro CAMPATH-1H for High Risk Diseases
Trial Start Date		1999-09-21
Registered in ClinicalTrials.gov		NCT00004143
Date Submitted to PDQ		1999-11-18
Information Last Verified		2006-11-16
NCI Grant/Contract Number		CA14236

Back to Top