Mesothelioma Clinical Trials
PV701 in
Treating Patients With Advanced or Recurrent Peritoneal
Cancer
This study is currently
recruiting patients.
Memorial Sloan-Kettering Cancer Center
For more information:National
Cancer Institute (NCI)
RATIONALE: PV701 may be able to kill tumor cells while
leaving normal cells undamaged.
PURPOSE: Phase I trial to study the effectiveness of PV701
in treating patients who have advanced or recurrentovarian
epithelial, fallopian tube, primaryperitoneal, colorectal, or
other cancer found primarily within the peritoneal cavity.
Condition
|
Treatment or
Intervention |
Endocrine Cancer female
reproductive cancer Gastrointestinal Cancer thorax
and respiratory cancer unclassified and other
cancer |
Drug: PV701 Procedure: gene
therapy
|
This is a Phase I test
- In Phase I clinical trials,
researchers test a new drug or treatment in a small
group of people (20-80) for the first time to evaluate its safety, determine
a safe dosage range, and identify side effects.
Study Type: Interventional Study
Design: Treatment
Official Title: Phase I Study of
Intraperitoneal PV701 in Patients With Advanced or Recurrent
Malignancy Largely Confined to the Peritoneal Cavity
Further Study Details:
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.
- 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).
- 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.
Ages Eligible for Study: 18 Years and
above, Genders Eligible for Study: Both
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
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