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A Phase I Clinical Trial To Assess The Safety And Efficacy Of Intraperitoneal PV701 Administrations In Patients With Advanced Or Recurrent Malignancy Largely Confined To The Peritoneal Cavity


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase I Clinical Trial To Assess The Safety And Efficacy Of Intraperitoneal PV701 Administrations In Patients With Advanced Or Recurrent Malignancy Largely Confined To The Peritoneal Cavity


OBJECTIVES:

- Determine the dose-limiting toxicity and maximum tolerated dose of intraperitoneal
PV701 after desensitization in patients with advanced or recurrent malignancy largely
confined to the peritoneal cavity these patients.

- Determine the optimal desensitization dose of intravenous PV701 in these patients.

- Determine the safety of this drug, in terms of cumulative toxicity, in these patients.

- Determine, preliminarily, the antitumor activity of this drug in these patients.

- Determine the presence and duration of viral shedding, viremia, and immunogenicity of
this drug.

OUTLINE: This is an open-label, dose-escalation study comprising 2 different treatment
schedules.

- Schedule I (optimal desensitization dose): Patients receive PV701 IV over 30 minutes on
day 1 followed by intraperitoneal (IP) PV701 on days 4, 7, and 9. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PV701 IV and IP until the optimal
desensitization dose (ODD) is determined. The ODD is defined as the dose preceding that at
which at least 2 of 6 patients experience dose-limiting toxicity (DLT).

- Schedule II (maximum tolerated dose):Patients receive the same regimen as in schedule I
using PV701 IV at the ODD.

Cohorts of 3-6 patients receive escalating doses of PV701 IP until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience DLT.

PROJECTED ACCRUAL: A total of 3-50 patients will be accrued for this study within 10-17
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histological confirmation of 1 of the following:

- Ovarian epithelial carcinoma

- Fallopian tube cancer

- Primary peritoneal cancer

- Advanced colorectal carcinoma

- Other malignancy confined to the peritoneal cavity or peritoneal surfaces

- No lesion greater than 2 cm in greatest diameter based on surgical re-assessment

- Low burden of tumor in the abdominal or pelvic cavities and no clinically significant
ascites

- Received potentially effective therapy when available (e.g., platinum/taxane for
ovarian cancer, fluoropyrimidine-based therapy for colorectal cancer)

- No concurrent hematological malignancy (e.g., chronic lymphocytic leukemia or
non-Hodgkin's lymphoma)

- No bilateral adrenal metastases

- No adrenal metastases in the remaining adrenal gland after adrenalectomy (including
radical nephrectomy)

- No lung tumors 5 cm or more

- No pleural effusions (at least 25% of hemithorax) by radiography

- No CNS metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- More than 3 months

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin greater than 9 g/dL

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 1.5 times ULN

- Alkaline phosphatase no greater than 1.5 times ULN

- No uncontrolled hepatic dysfunction

- No active hepatitis B or C

Renal

- See Disease Characteristics

- Creatinine no greater than 1.6 mg/dL AND/OR

- Creatinine clearance at least 50 mL/min

- No uncontrolled renal dysfunction

Cardiovascular

- No uncontrolled cardiovascular dysfunction

- No myocardial infarction within the past 6 months

- No life-threatening arrhythmias within the past 6 months

Pulmonary

- See Disease Characteristics

- No uncontrolled pulmonary dysfunction

- No pulmonary atelectasis (lobar)

- No pulmonary infiltrates (lobar)

- No pulmonary consolidation (lobar or segmental)

- No baseline grade II dyspnea

Adrenal

- See Disease Characteristics

- No uncontrolled adrenal dysfunction

- No known adrenal insufficiency

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled gastrointestinal dysfunction

- No neurological dysfunction

- No serious medical or psychological condition that would preclude study participation
or increase the risk of adverse effects of the study treatment

- No history of serious immunodeficiency

- No active uncontrolled bacterial infection (including asymptomatic urinary tract
infection)

- No contraindication to intraperitoneal therapy including the following:

- Intra-abdominal infection

- Dense widespread adhesions

- Peritonitis

- Periumbilical infection

- Bowel obstruction

- Ileostomy

- No hypersensitivity to eggs

- No continued contact with live birds (e.g., poultry farmers, veterinarians,
laboratory technicians, pet store owners, breeders)

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No more than 3 prior cytotoxic chemotherapy regimens

- More than 30 days since prior chemotherapy

Endocrine therapy

- More than 14 days since prior systemic corticosteroids

Radiotherapy

- More than 30 days since prior radiotherapy

Surgery

- See Disease Characteristics

- No prior complete or partial lobectomy with removal of lung tissue at least segmental
size

- No prior organ allograft

Other

- Recovered from prior therapy

- More than 14 days since prior antiviral medication

- More than 4 weeks since prior immunosuppressive drugs

- No other concurrent investigational drugs

- No concurrent chronic immunosuppressive drugs (e.g., cyclosporine)

- No vaccination for influenza within 48 hours of study drug administration

- No concurrent hypoglycemic agents

- No concurrent antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000270801

NCT ID:

NCT00055705

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Cancer
  • recurrent ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • ovarian sarcoma
  • recurrent ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent uterine sarcoma
  • stage IV uterine sarcoma
  • ovarian stromal cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • gastrointestinal stromal tumor
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • recurrent gastric cancer
  • stage IV gastric cancer
  • carcinoma of the appendix
  • small intestine adenocarcinoma
  • small intestine leiomyosarcoma
  • small intestine lymphoma
  • recurrent small intestine cancer
  • recurrent gallbladder cancer
  • unresectable gallbladder cancer
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021