Completed

Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+13

+ Adenocarcinoma

+ Carcinoma

See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2003
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic stem cell transplantation. OUTLINE: This is a pilot, multicenter study. * Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2, cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to -2. * Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for approximately 30 days. Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months after transplantation. PROJECTED ACCRUAL: A total of 20 patients (10 with HLA-identical related donors and 10 with matched unrelated donors) will be accrued for this study.

Official TitleAllogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma 
NCT00073879
Principal SponsorBaylor College of Medicine
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaCarcinoma, Renal CellFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of recurrent or metastatic renal cell carcinoma * Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2 * Clinically evident and followable disease * Availability of 1 of the following compatible donors: * Related HLA-identical or 1-Ag mismatched donor * Unrelated HLA-A, B, DRB1-matched donor PATIENT CHARACTERISTICS: Age * Any age Performance status * Karnofsky 70-100% Life expectancy * No concurrent illness that severely limits life expectancy Hematopoietic * Not specified Hepatic * No episode of hepatitis within the past month * No evidence of chronic active hepatitis or cirrhosis Renal * Creatinine no greater than 2 mg/dL Cardiovascular * LVEF at least 40% * No uncontrolled arrhythmias * No symptomatic cardiac disease Pulmonary * FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease) Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Baylor College of Medicine

Houston, United StatesSee the location
CompletedOne Study Center