MDACC Study Summary DM97-325

Study Summary
No. DM97-325:.......Hematologic Disorder......Muzaffar H. Qazilbash......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	DM97-325

Study Title:	A PHASE I/II STUDY OF PR1 (NSC698102) HUMAN LEUKEMIA PEPTIDE VACCINE WITH MONTANIDE ISA 51 (NSC 675756) OR MONTANIDE ISA 51 VG (NSC 737063) ADJUVANT

Physician

New Patient Referral



Name:	Muzaffar H. Qazilbash	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:	713-792-4326 Contact us about clinical trials

General Information



Disease Group:	Hematologic Disorder	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 3 weeks for the first 18 weeks For revaccination, every 3 weeks for a maximum of 18 weeks

Treatment Agents:	None	Home Care:	none

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	0


Description/ Intervention:	The goal of this clinical research study is to see how well a new vaccine (called PR1) for chronic myelogenous leukemia (CML), acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) causes an immune response in the body. The study will also look at the safety of the vaccine and find the safest dose of the vaccine.

Study Objectives / Outcomes

To evaluate toxicity of PR1 peptide administered subcutaneously.
To evaluate immunologic reactivity.
To evaluate possible therapeutic efficacy of PR1 peptide vaccine preparation with Incomplete Freund's Adjuvant (IFA), in high risk HLA-A2 positive patients with myeloid leukemias.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/03/2002

Study Type:

Recruitment Status:	Closed

Projected Accrual:	Total accrual will be 66.

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) Dx:CML in late chronic or early accelerated phase. MDS/AML not eligible for BMT,IFN, of failed standard therapy, or relapsed after BMT. All HLA A2+. ECOG PS<3. Life expectancy not limited by concomitant illness. Serum bilirubin<3 mg/dl, serum creatinine <2 mg/dl, no active uncontrolled infection, no effusion or ascites >1L prior to drainage. HIV negative. Not receiving steroids. NKA to incomplete Freund's Adjuvant (IFA). Pregnancy negative. Able to sign informed consent. Patients with immunological or clinical responses to PR1 vaccine may be retreated for disease progression.

Exclusion Criteria:

1) Any patient who does not meet Inclusion Criteria

Links

Registration Number: NCT00004918
Study Information on Clinical Trials Registry (clinicaltrials.gov)