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Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-TRICOM (rF-TRICOM) in Patients With Bladder Carcinoma Scheduled for Cystectomy


Phase 1
N/A
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Bladder, Recurrent Bladder Cancer, Squamous Cell Carcinoma of the Bladder, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Stage III Bladder Cancer, Transitional Cell Carcinoma of the Bladder

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Trial Information

Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-TRICOM (rF-TRICOM) in Patients With Bladder Carcinoma Scheduled for Cystectomy


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of neoadjuvant intravesical recombinant
fowlpox-TRICOM vaccine and/or recombinant fowlpox-sargramostim vaccine in patients with
bladder carcinoma who are scheduled for cystectomy.

II. Determine the dose-limiting toxic effects of these regimens in these patients.

SECONDARY OBJECTIVES:

I. Determine the local and systemic immunologic response in patients treated with these
regimens.

OUTLINE: This is an open-label, dose-escalation study. Patients are alternately assigned to
regimens A and B. Once regimens A and B have finished accrual, patients are assigned to
regimen C.

REGIMEN A: Patients receive recombinant fowlpox-sargramostim vaccine intravesically on days
1, 8, 15, and 22 for a total of 4 doses.

REGIMEN B: Patients receive recombinant fowlpox-TRICOM vaccine intravesically on days 1, 8,
15, and 22 for a total of 4 doses.

REGIMEN C: Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant
fowlpox-sargramostim vaccine intravesically on days 1, 8, 15, and 22 for a total of 4 doses.

In all regimens, the vaccine(s) is delivered into the bladder by urinary catheter and
retained for 2 hours. Treatment continues in the absence of disease progression or
unacceptable toxicity.

In all regimens, patients undergo cystectomy within 4-5 days after the last (4th)
intravesical instillation.

Cohorts of 3-6 patients in each regimen receive escalating doses of recombinant
fowlpox-sargramostim vaccine and/or recombinant fowlpox-TRICOM vaccine until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months for 2 years and then annually for 3 years.


Inclusion Criteria:



- Histologically confirmed cancer of the urinary bladder, including the following
cellular types:

- Transitional cell carcinoma

- Adenocarcinoma

- Squamous cell carcinoma

- Requires cystectomy as standard therapy and scheduled to undergo surgery

- Ineligible for neoadjuvant chemotherapy

- ECOG 0-1

- Life expectancy >= 6 months

- No active ischemic heart disease (i.e., New York Heart Association class III or IV
cardiac disease)

- No myocardial infarction within the past 6 months

- No history of congestive heart failure

- No history of ventricular arrhythmias or other arrhythmias requiring therapy

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

- Autoimmune neutropenia

- Thrombocytopenia or hemolytic anemia

- Systemic lupus erythematosus

- Sjögren's syndrome

- Scleroderma

- Myasthenia gravis

- Goodpasture's syndrome

- Addison's disease

- Hashimoto's thyroiditis

- Active Graves' disease

- No other immunodeficiency disease

- Not pregnant or nursing

- Negative pregnancy test

- All patients must abstain from sexual intercourse during and for at least 1 month
after final treatment dose

- No known allergy to eggs

- No prior exposure to liver toxins

- No ongoing alcohol consumption or exposure to other liver toxins

- No active uncontrolled infection

- No other active malignancy within the past 5 years except superficial squamous cell
or basal cell skin cancer or carcinoma in situ of the cervix or prostate

- No other medical illness that would preclude study participation

- No uncontrolled psychiatric illness that would preclude study compliance

- At least 4 weeks since prior immunotherapy

- At least 2 months since prior intravesical BCG

- No prior neoadjuvant chemotherapy

- At least 4 weeks since prior systemic chemotherapy

- At least 2 months since prior intravesical chemotherapy

- No concurrent or imminent steroid therapy

- No prior radiotherapy to the bladder

- At least 4 weeks since prior radiotherapy

- Recovered from prior therapy

- No concurrent acetaminophen

- No concurrent active antibiotic therapy except as prophylaxis

- No concurrent immunosuppressive therapy

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 75,000/mm^3

- No history of liver disease and/or history of hepatitis that may suggest persistent
disease

- SGOT less than 2 times normal

- Bilirubin less than 2.0 mg/dL

- No presence of liver function abnormalities

- Creatinine less than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min

- At least 4 weeks since prior systemic steroids

- No immunodeficiency disorder (e.g., AIDS, SCID, or Wiskott-Aldrich syndrome)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)

Outcome Time Frame:

Up to 39 days

Safety Issue:

Yes

Principal Investigator

Robert Weiss

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00020

NCT ID:

NCT00072137

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Bladder
  • Recurrent Bladder Cancer
  • Squamous Cell Carcinoma of the Bladder
  • Stage 0 Bladder Cancer
  • Stage I Bladder Cancer
  • Stage II Bladder Cancer
  • Stage III Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Transitional Cell

Name

Location

Cancer Institute of New JerseyNew Brunswick, New Jersey  08901