MDACC Study Summary 2005-0170 (Archived)

Study Summary
No. 2005-0170:.......Lymphoma......Sattva S. Neelapu......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2005-0170

Study Title:	Randomized Trial of Patient - Specific Vaccination with Conjugated Follicular Lymphoma - Derived Idiotype (FNHLId1) with Local GM-CSF in First Complete Remission

Physician

New Patient Referral



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

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase II/Phase III	Return Visit:	Minimum number of visits: Chemo at UTMDACC: 24 chemo visits; 18 lab visits; 7 clinic visits;3 BM visits; 3 CT visits; Then monthly injections x 5 . F/U 4 x year. then 2 x year until relapsed.

Treatment Agents:	Adriamycin Cytoxan Etoposide GM-CSF Id-KLH Prednisone Rituximab Vincristine	Home Care:	Outside physicians (including satellite clinic sites and local treating physicians) may administer PACE chemotherapy. Specific procedures as outlined in Appendices H, I and J will be followed when outside physicians administer chemotherapy.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to see if a cancer vaccine is able to get rid of tumor cells that remain after patients receive standard chemotherapy. If the vaccine is able to get rid of the remaining tumor cells, researchers want to also find out how long patients remain disease free.

Study Objectives / Outcomes

Primary Objective:

The primary objective of this trial is to definitively confirm the safety and efficacy of FNHLId1 (autologous immunoglobulin follicular lymphoma-derived idiotype vaccine) assessed by significant prolongation of clinical disease-free survival (DFS) following FNHLId1 immunization with GM-CSF in Follicular Lymphoma (FL) patients achieving a CR with standard dose chemotherapy, when compared to DFS following administration of KLH-KLH and GM-CSF.

Secondary Objectives:
To determine the ability of ID vaccine to produce a molecular CR in-subjects in clinical CR, but with PCR evidence of residual disease after standard chemotherapy.

To determine the impact of ID immunization on molecular DFS in FL subjects.

To evaluate the ability of ID vaccine to generate an immunology response against
autologous tumor.

To determine and compare the overall survival of subjects randomized to receive either
treatment assignment.

To evaluate the safety of a series of five immunization injections administered with GM-
CSF as adjunct therapy over a 6-month period.

Study Status Information



Study Activation / Registration Date:	03/07/2006

IRB Review and Approval Date:	10/05/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	563

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) Tissue diagnosis of follicular lymphoma with surface IgM or IgG phenotype with a monoclonal heavy and light chain as determined by Flow Cytometry. When a lymph node is biopsied to produce a vaccine, the NCI will histologically evaluate it. The histology of the biopsy must be Follicular Center Cell (FCC) grade I, II, or IIIa (follicular small-cleaved cell lymphoma, follicular mixed, or follicular large cell lymphoma with centrocytes).

2) Stage II with bulky adenopathy (> 5 cm in diameter), Stage III or IV lymphoma.

3) Only chemotherapy naive-subjects are eligible. Subjects may have received Prednisone (< 2 months of therapy).

4) Previous treatment with radiation alone (</= 2 sites) is permissible.

5) A single peripheral lymph node > 2 cm size accessible for biopsy/harvest or an abdominal lymph node > 2 cm that is accessible for laparoscopic biopsy. Subjects with lymphoma cells circulating in the peripheral blood, malignant pleural effusions, or malignant ascites may be eligible if adequate lymphoma cells are present (> 10^9).

6) ECOG performance status < 2, unless the performance is directly related to disease and therefore should improve with therapy.

7) Life expectancy of greater than one year.

8) Serum creatinine < 1.5 mg/dl unless felt to be secondary to lymphoma.

9) Bilirubin </= 1.5 mg/dl unless secondary to lymphoma or Gilbert's disease. SGOT/SGPT < 3.5 x upper limit of normal.

10) Ability to give informed consent. Ability to return to clinic for adequate follow-up for the period that the protocol requires.

Exclusion Criteria:

1) Any amount of radiation exceeding 2 sites, including prior total body irradiation (TBI).

2) Presence of antibodies to HIV, hepatitis B surface antigen or other active infectious process. HIV suppresses the immune system and causes other abnormalities of immunoregulation. Active infectious processes, including Hepatitis B, also cause abnormalities of immunorelation. This could potentially interfere with the development of an immune response to the tumor antigen.

3) Pregnancy or lactation. Chemotherapeutic agents are known to have teratogenic effects on developing embryos and to cause chromosomal damage to gametes. These agents also cause bone marrow suppression and can be excreted in milk. The effects of this type of vaccine on developing embryos is unknown. Since this therapy is not known to be curative, the potential risk to a fetus surpasses that of recognized benefit to the subject. Fertile men and women must plan to use effective contraception. A beta-HCG level will be obtained in women of childbearing potential.

4) A history of unrelated (non-lymphomatous) neoplasm within the past 10 years other than non-melonoma skin cancer or in-situ cervix cancer. Subjects with a prior diagnosis of malignancy more than 10 years may be entered into the study at the discretion of the Principal Investigator.

5) Subject unwilling to give informed consent.

6) Failure to meet any of the eligiblity criteria.

7) Any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the subject's ability to tolerate this treatment.

8) Subject with primary or secondary CNS lymphoma (current or previously treated) will not be eligible.

Links

Registration Number: NCT00091676
Study Information on Clinical Trials Registry (clinicaltrials.gov)