MDACC Study Summary 2005-0344 (Archived)

Study Summary
No. 2005-0344:.......Kidney......Naoto Ueno......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2005-0344

Study Title:	Multicenter Phase II Study of Non-myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma

Physician

New Patient Referral



Name:	Naoto Ueno	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8754 Contact us about clinical trials

General Information



Disease Group:	Kidney	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients must return to the clinic for study related follow-up visits at approx. 100 days, 6 mths and 1 year after transplantation. Follow-up beyond 1 year post transplant will be in accordance with existing NMDP's Protocols, Standards, and P&P.

Treatment Agents:	Fludarabine Melphalan	Home Care:	As per BMT standards, may resume most of patient's normal activities after transplant, but must take special precautions.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Most recipients require hospital stay for approximately 3-4 weeks after transplant. Patient must stay in Houston area for about 100 days after transplant.


Description/ Intervention:	The goal of this clinical research study is to find out the safety and effectiveness of a stem cell transplant from an unrelated donor for patients with kidney cancer that has spread to other parts of the body.

Study Objectives / Outcomes

Primary Objective: To determine the incidence of the best attained tumor response of CR + CRU + PR within 6 months after matched unrelated donor (MUD) allogeneic NST in subjects diagnosed with metastatic Renal Cell Carcinoma

Secondary Objectives:
1) To determine overall survival after MUD allogeneic NST
2) To determine the rate of complete donor myeloid and lymphoid chimerism after MUD allogeneic NST
3) To determine the incidence and severity of acute and chronic graft-versus-host disease (GVHD) after MUD allogeneic (NST). Death without GVHD will be considered a competing risk for this event
4) To determine the incidence of treatment-related mortality. Progression will be considered a competing risk for this event
5) To assess cytotoxic T lymphocyte reactivity
- To determine whether peptides derived from RCC antigen G250 and others can be used to elicit T cell immunity
- To determine whether CTL elicited against these antigens can lyse primary RCC cells or RCC cell lines
- To identify donor-derived anti-RCC T lymphocytes using MHC/peptide tetramer technology in the peripheral blood of both donors and recipients after transplant and in the tumor tissues of recipients, and correlate with clinical outcome
6) To assess antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect by probing sera using phage libraries, and identify antibodies that increase compared to pre-procedure or treatment levels and correlate with clinical response

Study Status Information



Study Activation / Registration Date:	02/28/2006

IRB Review and Approval Date:	12/21/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	50

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Age 18 to 65

2) Diagnosis of metastatic RCC (stage IV disease) with predominant conventional (clear) cell type.

3) Prior nephrectomy.

4) Karnofsky performance status > or = to 80.

5) Available HLA-matched (8/8, 7/8) unrelated donor (assessing high resolution typing at HLA A,B,C, DRB1).

6) At least one prior immunotherapy; immunotherapy + chemotherapy; or targeted therapy for metastatic RCC

7) Serum creatinine < or = to 2.0 mg/dL.

8) Serum bilirubin < or = to 1.5 mg/dL.

9) ALT (SGPT) or AST < or = to 3 x upper limit of normal.

10) Normal serum calcium.

11) Serum LDH level ≤ 1.5 x upper limit of normal

12) Signed informed consent.

13) Measurable disease at the time of study enrollment

Exclusion Criteria:

1) Prior history of allogeneic stem cell transplantation.

2) A diagnosis of RCC with histology other than conventional (clear) cell type.

3) History or presence of brain metastasis.

4) Progressive disease with more than 50% increase in diameter of nodules in three months.

5) Uncontrolled hypercalcemia.

6) Active infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (continued antibiotic therapy after signs/symptoms are resolved for > seven (7) days is not an exclusion).

7) HIV infection.

8) Pregnant or lactating women.

9) Severe, unstable or uncontrolled cardiac disease (e.g., arrhythmias or heart failure).

10) Severe, unstable or uncontrolled pulmonary disease.

Links

Registration Number: NCT00318110
Study Information on Clinical Trials Registry (clinicaltrials.gov)