Fallopian Tube CancerPhase 1NCT00002960
SCH-58500 in Treating Patients With Primary Ovarian, Fallopian Tube, or Peritoneal Cancer (C95084)
A Phase 1 study testing recombinant adenovirus-p53 SCH-58500 in people with Fallopian Tube Cancer and Metastatic Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
RATIONALE: Giving the p53 gene for ovarian, fallopian tube, or peritoneal cancer may inhibit tumor growth. Giving the gene directly into the peritoneum may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer
- What is being tested?
- recombinant adenovirus-p53 SCH-58500
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Jun 1999to Jul 2000
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Radiographic or surgical evidence of primary ovarian, fallopian tube, or peritoneal carcinoma Ascites cytologically positive for peritoneal carcinomatosis from recurrent or persistent ovarian, fallopian tube, or peritoneal carcinoma Must have ascites and tumor accessible by laparoscopic or percutaneous biopsy Immunohistochemical evidence of p53 gene mutation in the ascitic fluid cell block or primary tumor biopsy or other documented mutation
PATIENT CHARACTERISTICS: Age: 18 and over Life expectancy: At least 3 months Performance status: Karnofsky 60-100% Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 1.5 times the upper limit of normal (ULN) Alkaline phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Other: Ability to tolerate paired paracenteses or biopsies (percutaneous or laparoscopic) HIV negative No adenoviral infections determined by ELISA screening No uncontrolled serious bacterial, viral, fungal or parasitic infection No known or suspected hypersensitivity to study drug or any excipient used in formulation or delivery system No underlying medical condition that would obscure interpretation of adverse events Not pregnant or nursing Fertile patients must use effective contraception for at least 1 month before, during, and 6 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior biologic therapy and recovered Chemotherapy: At least 3 months since local intraperitoneal antitumor therapy directed against peritoneal carcinomatosis and recovered At least 1 month since systemic chemotherapy for ovarian, fallopian tube, or peritoneal cancer or an unapproved indication and recovered Endocrine therapy: At least 3 months since any systemic corticosteroid therapy Radiotherapy: At least 1 year since prior total abdominal radiotherapy Surgery: Not specified Other: At least 3 months since prior investigational therapy and recovered At least 3 months since prior immunosuppressive therapy
About this study
Official title: A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 (rAd/p53) Administered by Single Intraperitoneal Instillation
RATIONALE: Giving the p53 gene for ovarian, fallopian tube, or peritoneal cancer may inhibit tumor growth. Giving the gene directly into the peritoneum may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SCH-58500 in treating patients who have recurrent or persistent primary ovarian, fallopian tube, or peritoneal cancer.
Read the detailed description
OBJECTIVES: I. Assess the safety of SCH-58500 (recombinant adenoviral vector containing p53 tumor suppressor gene) when given as a single or multiple intraperitoneal instillation in combination with chemotherapy to patients with peritoneal carcinomatosis demonstrating p53 mutant ovarian, fallopian tube, or peritoneal carcinoma. II. Assess the biological activity of SCH-58500 by confirming wild type p53 gene expression. III. Assess the stability of SCH-58500 infection and expression by collection and analysis of serial, posttreatment, ascites specimens in a subset of 5 patients. IV. Assess the pharmacokinetics of SCH-58500 by serum and peritoneal fluid measurements. V. Document any clinical evidence of antitumor activity in these patients treated with this regimen.
OUTLINE: This is an abbreviated dose escalation, multicenter study of SCH-58500. Patients receive SCH-58500 by intraperitoneal instillation on days 1-5 (depending on dose level). Patients undergo ascites fluid and tumor sampling before and after intraperitoneal instillation. The ascitic fluid or tumor and normal tissue are then submitted for cytologic or histopathologic examination and biological activity analysis. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until 3 patients experience dose limiting toxicity or until the highest planned dose is reached. Patients are followed at 2 months, every 3 months for 1 year, and then yearly thereafter.
PROJECTED ACCRUAL: A total of 6-60 patients will be accrued for this study.
- Conditions
- Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Being tested
- recombinant adenovirus-p53 SCH-58500
- Keywords
- recurrent ovarian epithelial cancer, malignant ascites, fallopian tube cancer, primary peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant adenovirus-p53 SCH-58500Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2004 (estimated)
- Study startJun 1999
- Primary completionJul 2000
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jo Ann Horowitz, MD, Study chair, Schering-Plough
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002960
- Sponsor's protocol ID
- C95084
- Other IDs
- SPRI-I/C95-084, NCI-V97-1181
- Status last verified
- Feb 2016
- First submitted
- 1 Nov 1999
- Last updated
- 4 Feb 2016
- Results posted
- No
Publications
Buller RE, Shahin MS, Horowitz JA, Runnebaum IB, Mahavni V, Petrauskas S, Kreienberg R, Karlan B, Slamon D, Pegram M. Long term follow-up of patients with recurrent ovarian cancer after Ad p53 gene replacement with SCH 58500. Cancer Gene Ther. 2002 Jul;9(7):567-72. doi: 10.1038/sj.cgt.7700473.
PubMed 12082456Buller RE, Runnebaum IB, Karlan BY, Horowitz JA, Shahin M, Buekers T, Petrauskas S, Kreienberg R, Slamon D, Pegram M. A phase I/II trial of rAd/p53 (SCH 58500) gene replacement in recurrent ovarian cancer. Cancer Gene Ther. 2002 Jul;9(7):553-66. doi: 10.1038/sj.cgt.7700472.
PubMed 12082455
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 (rAd/p53) Administered by Single Intraperitoneal Instillation
- ClinicalTrials.gov ID
- NCT00002960
- Acronym / sponsor ID
- C95084
- Conditions
- Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Keywords
- recurrent ovarian epithelial cancer, malignant ascites, fallopian tube cancer, primary peritoneal cavity cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- Primary completion
- Jul 2000 (actual)
- Study completion
- Jul 2000 (actual)
- First posted
- 24 Aug 2004 (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: Giving the p53 gene for ovarian, fallopian tube, or peritoneal cancer may inhibit tumor growth. Giving the gene directly into the peritoneum may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SCH-58500 in treating patients who have recurrent or persistent primary ovarian, fallopian tube, or peritoneal cancer.
Detailed description
OBJECTIVES: I. Assess the safety of SCH-58500 (recombinant adenoviral vector containing p53 tumor suppressor gene) when given as a single or multiple intraperitoneal instillation in combination with chemotherapy to patients with peritoneal carcinomatosis demonstrating p53 mutant ovarian, fallopian tube, or peritoneal carcinoma. II. Assess the biological activity of SCH-58500 by confirming wild type p53 gene expression. III. Assess the stability of SCH-58500 infection and expression by collection and analysis of serial, posttreatment, ascites specimens in a subset of 5 patients. IV. Assess the pharmacokinetics of SCH-58500 by serum and peritoneal fluid measurements. V. Document any clinical evidence of antitumor activity in these patients treated with this regimen.
OUTLINE: This is an abbreviated dose escalation, multicenter study of SCH-58500. Patients receive SCH-58500 by intraperitoneal instillation on days 1-5 (depending on dose level). Patients undergo ascites fluid and tumor sampling before and after intraperitoneal instillation. The ascitic fluid or tumor and normal tissue are then submitted for cytologic or histopathologic examination and biological activity analysis. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until 3 patients experience dose limiting toxicity or until the highest planned dose is reached. Patients are followed at 2 months, every 3 months for 1 year, and then yearly thereafter.
PROJECTED ACCRUAL: A total of 6-60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- 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 |
|---|---|---|
| recombinant adenovirus-p53 SCH-58500 | 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 4 Feb 2016.
- Results publication: PubMed 12082456Buller RE, Shahin MS, Horowitz JA, Runnebaum IB, Mahavni V, Petrauskas S, Kreienberg R, Karlan B, Slamon D, Pegram M. Long term follow-up of patients with recurrent ovarian cancer after Ad p53 gene replacement with SCH 58500. Cancer Gene Ther. 2002 Jul;9(7):567-72. doi: 10.1038/sj.cgt.7700473.
- Results publication: PubMed 12082455Buller RE, Runnebaum IB, Karlan BY, Horowitz JA, Shahin M, Buekers T, Petrauskas S, Kreienberg R, Slamon D, Pegram M. A phase I/II trial of rAd/p53 (SCH 58500) gene replacement in recurrent ovarian cancer. Cancer Gene Ther. 2002 Jul;9(7):553-66. doi: 10.1038/sj.cgt.7700472.
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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.
Jo Ann Horowitz, MD study chair
Schering-Plough
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant adenovirus-p53 SCH-58500 in people with Fallopian Tube Cancer and Metastatic Cancer, run by Merck Sharp & Dohme LLC.
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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT00002960, which also lists 2 linked publications.
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 4 Feb 2016.