CancerPhase 1NCT00055705
PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
A Phase 1 study testing PV701 in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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 recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or other cancer found primarily within the peritoneal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PV701
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: 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
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 recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or other cancer found primarily within the peritoneal cavity.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- PV701
- Keywords
- 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
- Medical subject headings
- Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Colonic Neoplasms, Endometrial Neoplasms, Rectal Neoplasms, Gastrointestinal Stromal Tumors, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PV701Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David R. Spriggs, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055705
- Sponsor's protocol ID
- CDR0000270801
- Other IDs
- MSKCC-02080, NCI-1617
- Status last verified
- Aug 2004
- First submitted
- 6 Mar 2003
- Last updated
- 26 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00055705
- Acronym / sponsor ID
- CDR0000270801
- Conditions
- Cancer
- Keywords
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2003
- First posted
- 7 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or other cancer found primarily within the peritoneal cavity.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PV701 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R. Spriggs, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PV701 in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2011.