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CompletedNCT00004008Updated Jun 26, 2013

Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

A Phase 2 interventional study of bryostatin 1 in Ovarian Cancer, sponsored by University of Glasgow. Completed at 4 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.

Sponsored by University of Glasgow · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
Female
01

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy.

Read the detailed description

OBJECTIVES:

  • Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer.
  • Determine the response rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 24 hours. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or regressive disease may receive additional treatment.

Patients are followed for at least 4 weeks after treatment, then every 3 months.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

Browse Ovarian Neoplasms studies →

Lead sponsor

University of Glasgow is the lead sponsor of 141 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically proven ovarian epithelial cancer

    • Progressive disease during or after completion of at least one platinum based chemotherapy regimen
  • Bidimensionally measurable disease

    • At least 2 cm by x-ray, CT scan, or ultrasound
  • No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Hemoglobin at least 10 g/dL
  • WBC at least 4,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.7 mg/dL
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.4 mg/dL

Other:

  • No active, uncontrolled infection
  • No nonmalignant systemic disease which would increase risk to patient
  • No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered
  • No more than 2 prior multidrug chemotherapy regimens
  • No more than 1 prior single agent chemotherapy regimen

Endocrine therapy:

  • At least 4 weeks since prior endocrine therapy and recovered
  • No concurrent steroids
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered
  • No concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major thoracic or abdominal surgery

Other:

  • No other concurrent anticancer therapy or investigational drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Drugbryostatin 1
06

Study locations

4 sites
  • Christie Hospital N.H.S. Trust
    Manchester, England M20 4BX, United Kingdom
  • Oxford Radcliffe Hospital
    Oxford, England 0X3 9DU, United Kingdom
  • Weston Park Hospital
    Sheffield, England S1O 2SJ, United Kingdom
  • Royal Infirmary
    Glasgow, Scotland G4 0SF, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004008
Lead sponsor
University of Glasgow
First posted
May 8, 2003
Start date
Jul 1999
Completion
May 2003
Last update
Jun 26, 2013

Study contacts

Gordon Jayson, MD
study chair · The Christie NHS Foundation Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 1999. You cannot join it, but the record below documents what was studied.

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