Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission

NCT01248273 | Completed Phase 1 DMC

• 1 other identifier: 09-184
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerprints" are found on many cancer cells, especially from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this study is to see if investigators can help the immune system to recognize that cancer cells are not normal and should be removed.

Conditions

Fallopian Tubes; Ovarian Cancer; Peritoneal Cancer

Keywords

GLOBO H-KLH CONJUGATE; MUC-1 KLH; QS-21; TF(C)-KLH; TN(C)-KLH; Immunization; Vaccine; 09-184

Outcome Measures

Primary Outcomes (3)

• To determine immunologic response

  immunization with the unimolecular pentavalent carbohydrate-based vaccine bearing Globo-H, GM2, sTn, TF and Tn on a single polypeptide backbone, conjugated to KLH, mixed with the immunological adjuvant QS-21, induces an IgG and IgM antibody response against these individual antigens and tumor cells expressing these antigens.

  6 months

• To determine the toxicities following immunization with this unimolecular polyvalent vaccine.

  Toxicity will be graded in accordance with the Common Toxicity Criteria Version 4.0 developed by the National Cancer Institute (NCI).

  2 years

• To determine the maximum tolerated dose over three dose levels.

  Six patients will be accrued to one of three pentavalent vaccine doses (25 mcg, 50 mcg and 100 mcg), and an expansion cohort of six patients will be enrolled at the highest dose level achieved.

  2 years

Secondary Outcomes (1)

• To record the progression free interval

  2 years

Study Arms (1)

immunization

EXPERIMENTAL

This trial will investigate the safety and immune responses following immunization with the unimolecular pentavalent Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21. This is a phase I study to assess toxicity and immunogenicity.

Biological: Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21

Interventions

Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21 BIOLOGICAL

The injection will be administered subcutaneously during weeks 1, 2, 3, 7 and 19, totaling five injections over the course of the study. Three dose levels are planned: 25 mcg, 50 mcg and 100 mcg. We plan to vaccinate six patients at each dose level unless 2 dose limiting toxicities are observed, and an expansion cohort of 6 patients will be enrolled at the highest dose level achieved.

immunization

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any histologically documented stage III or IV epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.
• History of cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment.
• Patients must be in a first complete clinical remission. Complete clinical remission is defined as serum CA-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm are often present in the pelvis and will not be considered definite evidence of disease. Eligibility is determined by anatomical imaging only (ie. MRI or CT). Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative.
• Adequate organ function defined by
• Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³, grade 1. Platelets greater than or equal to 100,000/mm³.
• Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1.
• Hepatic function: Bilirubin, SGOT, and alkaline phosphatase less than or equal to 2.5 x ULN
• Negative stool hemoccult (or negative endoscopic evaluation if positive). External hemorrhoids are a common source of a positive hemoccult and should not exclude patients.
• TSH not elevated above normal range
• KPS \> or = to 80%.
• Patients have signed the informed consent document and signed the authorization permitting release of personal health information.
• Age \> 18 years
• Patients must have recovered from clinically significant side effects from prior chemotherapy

You may not qualify if:

• Pregnant or nursing women
• Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years, or whose previous cancer treatment contraindicated this protocol therapy are excluded. Non-melanoma skin cancers are an exception and will not exclude any patient.
• Patients with a history of a seafood allergy.
• Patients who have previously received a vaccine with any of the antigens in the current trial.
• Patients with a history of immunodeficiency or autoimmune disease (excluding treated hypothyroidism).
• Patients with active CNS tumor.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

• Paul Sabbatini, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (1)