Stage III Ovarian Cancer, Stage IV Ovarian Cancer
Conditions
Keywords
ovarian cancer
Brief summary
This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.
Interventions
BIOLOGICALVigil™ Vaccine
Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
DRUGCarboplatinum
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
DRUGCarboplatinum and Taxol
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
Sponsors
Gradalis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed papillary serous or endometrioid ovarian cancer. 2. Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify. 3. Recurrent cisplatinum-sensitive disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements after a 6 month period after platinum treatment. 4. Successful manufacturing of 4 vials of Vigil™ vaccine. 5. Recovered from all clinically relevant toxicities related to prior therapies. 6. ECOG PS 0-2 prior to Vigil™ vaccine administration. 7. Normal organ and marrow function as defined below: 1. Absolute granulocyte count ≥ 1,500/mm3 2. Absolute lymphocyte count ≥ 200/mm3 3. Platelets ≥ 100,000/mm3 4. Total bilirubin ≤ 1.5 x ULN 5. AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤ 2.5 x ULN 6. Creatinine \< 1.5 mg/dL 8. Patients must be off all statin drugs for ≥ 2 weeks prior to initiation of therapy. 9. Ability to understand and the willingness to sign a written informed protocol specific consent.
Exclusion criteria
1. Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination. 2. Patient must not have received any other investigational agents within 4 weeks prior to study entry. 3. Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation. 4. Patients with history of brain metastases. 5. Patients with compromised pulmonary disease. 6. Short term (\<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. 7. Prior splenectomy. 8. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years. 9. Kaposi's Sarcoma. 10. Patients with peripheral neuropathy ≥2 (paclitaxel). 11. Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements. 12. Patients with known HIV. 13. Patients with chronic Hepatitis B and C infection. 14. Patients with uncontrolled autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Up to 12 months | Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. |
| Time to Progression (TTP) | 24 months | Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune Analysis in Blood | Baseline, End of Treatment (30 days after last dose) up to 12 months | To determine if subjects will have a positive (defined as \>10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Alive Subjects | 24 months | Survival status of patients after treatment will be determined. |
Countries
United States
Participant flow
Recruitment details
This study recruited subjects from CL-PTL-105 who recurred and were either randomized to the control/observation arm (Group B) or screen-failed but had successful manufacturing of Vigil (minimum of 4 doses).
Pre-assignment details
1 subject was enrolled and administered Vigil plus Carboplatinum. This subject did not complete treatment due to disease progression.
Participants by arm
| Arm | Count |
|---|---|
| Vigil™ Vaccine Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease Progression | 1 |
Baseline characteristics
| Characteristic | Vigil™ Vaccine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Response Rate
Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
Time frame: Up to 12 months
Population: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.
Primary
Time to Progression (TTP)
Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.
Time frame: 24 months
Population: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.
Secondary
Immune Analysis in Blood
To determine if subjects will have a positive (defined as \>10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.
Time frame: Baseline, End of Treatment (30 days after last dose) up to 12 months
Population: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 12 months, subject had positive ELISPOT response. Statistical analysis was not done. This study was terminated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vigil™ Vaccine | Immune Analysis in Blood | ELISPOT-Positive After 12 months | 1 Participants |
| Vigil™ Vaccine | Immune Analysis in Blood | ELISPOT-Negative After 12 months | 0 Participants |
Other Pre-specified
Number of Alive Subjects
Survival status of patients after treatment will be determined.
Time frame: 24 months
Population: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 24 months, subject was not alive. Statistical analysis was not done. This study was terminated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vigil™ Vaccine | Number of Alive Subjects | Alive Subjects After 24 months | 0 Participants |
| Vigil™ Vaccine | Number of Alive Subjects | Dead Subjects After 24 months | 1 Participants |