A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant With Ovarian, Tubal or Peritoneal Cancer

Sponsor

Michael Morse, MD (Other)

Overall Status

Completed

CT.gov ID

NCT00437502

Collaborator

Immunotope (Industry)

Enrollment

Location

Arm

34.1

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety of administering a peptide vaccine consisting of twelve different tumor-rejection antigens known to be present on ovarian tumor cells. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.HLA-A2+ is a required criteria for subject eligibility.

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian, Tubal or Peritoneal Cancer	Biological: tumor peptide vaccine Biological: tumor peptide vaccine	Phase 1

Detailed Description

The primary endpoint will be to determine the safety and feasibility of administering ovarian cancer peptides to women who have undergone debulking surgery and systemic chemotherapy, with the secondary objectives of evaluating immune response as measured by ELISPOT to the immunizations, to compare the immune response as measured by ELISPOT achieved by the two different dosing strategies and to assess disease relapse survival. Two cohorts of 9 patients each will be treated with different doses of the OCPM vaccine. They will receive the peptide vaccine subcutaneously on weeks 0,1,2,3,5 and6 and then receive the immunizations every 1 month for 6 months or disease recurrence. The first 9 patients will be entered into the first cohort; if 1 or fewer patients experience Dose-limiting toxicity (DLT) then the next 9 will be enrolled into the second cohort. DLT is defined as any Grade 3 or greater hematologic or non-hematologic toxicity or autoimmune disease (except for fever, skin reaction, or alopecia which would be grade 4) occurring at any time from the first immunization until 30 days after the last immunization. Toxicity will be assessed at each dose level using CTC toxicity criteria. Ovarian cancer peptide-specific immune response will be measured by ELISpot. Time to disease relapse will be based on composite assessment of clinical signs, objective exam findings, radiologic imaging, and CA125 results. A dosing scheme will be considered safe if <1 of the first 9 subjects treated at a dose level experience DLT (as described above). A subject will be considered evaluable for safety if treated with at least one immunization. A T cell response will be considered positive by ELISpot if: the mean number of spots in six wells with antigen exceeds the number of spots in six control wells by 10 and the difference between single values of the six wells containing antigen and the six control wells is statistically significant at a level of p ≤ 0.05 using Student's t test.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women With Advanced Stage Ovarian, Tubal, or Peritoneal Cancer

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tumor peptide vaccine 2 cohorts: High and low dose tumor peptide vaccine	Biological: tumor peptide vaccine Cohort 1 low dose level of vaccine @ 0.3 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6. Biological: tumor peptide vaccine Cohort 2 high dose vaccine @ 1 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.

Arm

Intervention/Treatment

Experimental: tumor peptide vaccine

2 cohorts: High and low dose tumor peptide vaccine

Biological: tumor peptide vaccine

Cohort 1 low dose level of vaccine @ 0.3 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.

Biological: tumor peptide vaccine

Cohort 2 high dose vaccine @ 1 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.

Outcome Measures

Primary Outcome Measures

Date of first objective finding will be used to define the date of relapse [From date of enrollment to date of confirmed relaspe]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be HLA-A2+ patients with histologically confirmed, stage III-IV epithelial ovarian, tubal, or peritoneal cancer who have undergone optimal debulking and had a complete clinical response to front-line platin/taxane based chemotherapy.

Subjects must have received front-line platin compound and taxane chemotherapy following primary surgical resection. Front-line treatment can include up to 12 cycles of treatment.Subjects must receive the first dose of study medication at least 4 weeks and up to 6 months since completing their last dose of front-line chemotherapy.A complete clinical response defined as: no evidence of disease on physical exam,CT imaging scans of the abdomen and pelvis, chest x-ray and a CA-125 below the upper limit of normal.

Exclusion Criteria:

History of autoimmune disease, serious intercurrent chronic or acute illness, active hepatitis, serologic evidence for HIV, splenectomy, or be receiving steroid or immunosuppressive therapy.