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A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma



- Compare 2-year disease-free survival of patients with completely resected hepatic or
pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine
therapy comprising vaccinia-CEA-MUC-1-TRICOM vaccine (PANVAC-V) and
fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic
cells or with sargramostim (GM-CSF).


- Compare the rate and magnitude of immune response, as determined by ELISpot, in
patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo leukapheresis to obtain leukocytes for generation of autologous
dendritic cells (DC). Patients then receive autologous DC loaded with
vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID)
on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC
and ID on days 28, 56, and 84.

- Arm II: Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84.
Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily
on days 0-3, 28-31, 56-59, and 84-87.

After completion of study treatment, patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this
study within 2 years.

Inclusion Criteria


- Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma
of the colon and rectum

- Must have undergone complete resection of hepatic or pulmonary metastases with
curative intent

- No evidence of gross residual disease after surgery

- One or more resected and ablated lesions allowed provided all gross residual
tumor was destroyed by ablation

- Repeated resections of hepatic metastatic disease or resections of extrahepatic
metastases prior to resection of the hepatic metastases allowed provided the
most recent hepatic metastatic resection included total disease resection and/or

- Must have received at least 2 months of perioperative systemic chemotherapy
(including preoperative and/or postoperative chemotherapy) that was completed at
least 1 month ago



- At least 18

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 6 months


- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 8.5 g/dL (transfusion or epoetin alfa allowed)


- Bilirubin ≤ 2.0 mg/dL

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

- No other serious chronic or acute hepatic disease


- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance > 60 mL/min


- No New York Heart Association class III or IV cardiac disease

- No other serious chronic or acute cardiac disease


- No asthma

- No chronic obstructive pulmonary disease

- No other serious chronic or acute pulmonary disease


- No history of autoimmune disease, including, but not limited to, any of the

- Inflammatory bowel disease

- Systemic lupus erythematosus

- Ankylosing spondylitis

- Scleroderma

- Multiple sclerosis

- No HIV infection by ELISA and western blot

- Not immunocompromised (by disease or therapy)

- No allergy to eggs or any component of the study vaccine

- No history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination

- No allergy or untoward reaction to sargramostim (GM-CSF)

- No active acute or chronic infection, including urinary tract infection within the
past 72 hours

- No inflammatory bowel conditions, including, but not limited to, the following:

- Active infectious enteritis

- Eosinophilic enteritis

- No acute, chronic, or exfoliative skin disorders, including any of the following:

- Extensive psoriasis

- Burns

- Impetigo

- Disseminated zoster

- Varicella zoster

- Severe acne

- Other open rashes or wounds


- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to avoid close contact or household contact for 3 weeks after each vaccination
with the following individuals:

- Children under 5 years of age

- Pregnant or nursing women

- Individuals with prior or concurrent extensive eczema, other eczematoid skin
disorders, or other acute or chronic skin conditions

- Immunosuppressed or immunodeficient individuals

- No medical or psychological condition that would preclude study compliance

- No extensive eczema

- No other serious chronic or acute illness that would preclude study participation

- No other malignancy within the past 5 years except nonmelanoma skin cancer,
controlled superficial bladder cancer, or previously treated carcinoma in situ of the


Biologic therapy

- No other concurrent immunotherapy


- See Disease Characteristics

- No concurrent chemotherapy

Endocrine therapy

- More than 6 weeks since prior and no concurrent steroid therapy


- No concurrent radiotherapy


- See Disease Characteristics


- No other concurrent immunosuppressants (e.g., azathioprine or cyclosporine)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival at 2 years

Safety Issue:


Principal Investigator

Michael A. Morse, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • liver metastases
  • adenocarcinoma of the colon
  • recurrent colon cancer
  • stage IV colon cancer
  • adenocarcinoma of the rectum
  • recurrent rectal cancer
  • stage IV rectal cancer
  • lung metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Duke Comprehensive Cancer Center Durham, North Carolina  27710
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157