Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

NCT00305760 | Completed Phase 2 Results DMC

• 3 other identifiers: J0501P30CA006973BMS-CA225247
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer; recurrent pancreatic cancer; duct cell adenocarcinoma of the pancreas; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population

  7 months

Study Arms (1)

Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab

EXPERIMENTAL

Drug: Cetuximab; Biological: Pancreatic tumor vaccine; Drug: Cyclophosphamide

Interventions

Cetuximab DRUG

Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.

Also known as: Erbitux

Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab

Pancreatic tumor vaccine BIOLOGICAL

Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.

Also known as: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine, GVAX

Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab

Cyclophosphamide DRUG

Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.

Also known as: Cytoxan

Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed ductal adenocarcinoma of the pancreas * Mixed adenocarcinoma tumors eligible provided the predominant invasive component of the tumor is adenocarcinoma * The following histologic diagnoses are not eligible: * Adenosquamous * Squamous cell * Colloid * Islet cell * Serous or mucinous cystadenoma or cystadenocarcinoma * Carcinoid * Small or large cell carcinoma * Intraductal oncocytic papillary neoplasms * Osteoclast-like giant cell tumors * Acinar cell carcinoma * Pancreatoblastoma * Solid pseudopapillary tumors * Undifferentiated small cell carcinoma * Nonepithelial tumors (sarcoma, gastrointestinal stromal tumor, lymphoma) * Adenocarcinomas of the ampulla, distal bile duct, or duodenum * Metastatic or locally advanced disease that is refractory to standard therapy OR for which patient refused standard therapy * Measurable disease defined as ≥ 1 lesion unidimensionally measured as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * No nonmeasurable disease only including, but not limited to, the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural or pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * No known active or untreated brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,500/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 90,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2 mg/dL * ALT and AST ≤ 5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 5 times ULN * No active infection * No uncontrolled medical condition that would potentially increase the risk of toxicities or complications of study therapy * No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation * No active peptic ulcer disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No other malignancy within the past 5 years except for nonmelanomatous skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix * HIV negative * No active autoimmune disease or prior autoimmune disease requiring medical treatment with systemic immunosuppressants including any of the following: * Inflammatory bowel disease * Systemic vasculitis * Scleroderma * Psoriasis * Multiple sclerosis * Hemolytic anemia or immune thrombocytopenia * Rheumatoid arthritis * Systemic lupus erythematosus * Sjögren's syndrome * Sarcoidosis * Asthma or chronic obstructive pulmonary disease that does not require systemic corticosteroids or routine use of inhaled steroids allowed * No known or suspected hypersensitivity to sargramostim (GM-CSF), cyclophosphamide, pentastarch, corn, or DMSO * No prior severe infusion reaction (\> grade 3) to a monoclonal antibody PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 1 month since prior adjuvant chemotherapy * More than 4 weeks since prior surgery except for minor procedures (e.g., dental work, skin biopsy) and biliary stent placement * No prior surgical procedures affecting absorption * More than 4 weeks since prior radiotherapy * More than 1 month since prior participation in an investigational new drug study * No unresolved chronic toxicity (except alopecia) from prior anticancer therapy * More than 28 days since prior systemic steroids * No concurrent systemic steroids or immunosuppressive drugs * Topical, inhaled, and intra-articular steroids allowed * No other concurrent anticancer vaccine therapy * No other concurrent chemotherapy, immunotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Cyclophosphamide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Daniel Laheru
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

laherda@jhmi.edu

410-955-8974

Study Officials

• Daniel A. Laheru, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: December 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 19, 2020
• Results First Posted: July 15, 2015

Record last verified: 2020-02

Locations

US (1)