Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients

NCT00478452 | Completed Phase 1 DMC

• 2 other identifiers: 707800UPCC 01803
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized Phase I/II study designed to assess the induction of an anti-tumor immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine, with or without a single dose of cyclophosphamide. Potential benefit may range from no direct benefit to the study participants to stimulation of the subject's own immune system to attack ovarian cancer to prevent relapse.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• To assess the immunogenicity (with or without prior cyclophosphamide administration) of IDD-6, a peptide-loaded matured DC vaccine.

  Immunogenicity will be assessed by determining the frequency of specific HLA A -restricted T cells following vaccination with her2/neu, hTERT and PADRE -loaded DC

  24 months

Study Arms (2)

DC Ova

EXPERIMENTAL

DC Ova vaccine administered day 2 and week 3,6,9

Biological: DC-Ova

DC Ova with Cyclophosphamide

ACTIVE COMPARATOR

Cyclophosphomide administered at day 0 prior to administration of DC Ova vaccine administered day 2 and week 3,6,9

Biological: DC Ova with Cyclophosphamide

Interventions

DC-Ova BIOLOGICAL

DC Ova

DC Ova with Cyclophosphamide BIOLOGICAL

DC Ova with Cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The following conditions must be met before a patient may be enrolled in the study.
• Patients age 18 years of age and older.
• Disease Criteria. Patients will be eligible:
• If no clinical evidence of disease is present after diagnosis with stage III or
• IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.or primary peritoneal carcinoma.
• Complete clinical response = no evidence of tumor lesions shown by abdominal CT scan or MRI, chest Xray,and CA 125 level ≤ 35 UI/mL.
• Time from completion of Chemotherapy will be no more than 6 months from last dose from initial diagnoses.
• HLA-A2 positive (must be typed by molecular methods; all A2 alleles eligible).
• Patients with adequate organ function as measured by:
• Hematopoietic: WBC at least 3000/mm3; platelets at least 100,000/mm3, hemoglobin at least 10.0 g/dL (may be transfused).
• Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at rest must be ≥50% or within the normal range of the institution. A cardiology clearance will be required for LV ejection fraction \<50%.
• Hepatic: SGOT within 2x normal range and total bilirubin ≤ 2.0 mg/dL.
• Renal: Serum creatinine ≤2.0 mg/dL
• Adequate performance status \> 80% (Karnofsky) or ECOG 0-2
• Written informed consent conforming to institutional guidelines.

You may not qualify if:

• Any one of the following conditions eliminates a patient from participating in this protocol.
• Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years.
• Presence of active Central Nervous System disease.
• Serious systemic disease.
• Active bacterial, viral or fungal infections.
• Chemotherapy, biologic therapy or radiation therapy less than 4 weeks prior to study entry.
• History of active autoimmunity or immunosuppression.
• Use of immunosuppressive drugs within 4 weeks prior to study entry or anticipated use of immunosuppressive agents.
• Patients with tumors of low malignant potential (borderline tumors) will not be eligible.
• Seropositivity for HIV, HTLV-1, or HTLV-2.
• Prior Influenza vaccination with the current vaccine will exclude patient from receiving protocol-specified influenza vaccine but will not exclude participation with the other aspects of the protocol. Each year's vaccine supply generally becomes available in October. Patients with a history of serious hypersensitivity to eggs, previous influenza vaccine or its components, will not receive influenza vaccine, but may continue to participate in other aspects of the protocol. Patients with a history of serious hypersensitivity to the Prevnar vaccine, its components, or diptheria toxoid will not receive the Prevnar vaccine, but may continue to participate in other aspects of the protocol.
• Pregnant or breast feeding subjects.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Fox Chase Cancer Center: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• University of Pennsylvania Abramson Cancer Center Web Line

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Christina Chu, MD

  University of Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to cyclophosphamide 300 mg/m2 (arm 2) or no cyclophosphamide (arm 1). All subjects will receive intradermal injections of DC on day 2 and on week 3, 6, and 9 (+ 3 days). All subjects will undergo leukocyte apheresis at study enrollment and at week 10, which is the end of active study intervention. All study arm patients (1 and 2) will receive a single dose of trivalent killed influenza vaccine, and a single dose of Prevnar pneumococcal vaccine on the day they receive their first intradermal injections of DC on day 2.

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: August 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

US (1)