Mesothelioma Clinical Trials
Treating Patients With Advanced or Recurrent Peritoneal
This study is currently
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.
and respiratory cancer
unclassified and other
| Drug: PV701|
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
Official Title: Phase I Study of
Intraperitoneal PV701 in Patients With Advanced or Recurrent
Malignancy Largely Confined to the Peritoneal Cavity
Further Study Details:
- 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
- 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
- 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
- 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
- No CNS metastases by CT scan or