GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

NCT00157573 | Completed Phase 2 Results

• 1 other identifier: 04-305
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.

Conditions

Ovarian Cancer; Fallopian Tube Cancer

Keywords

Asymptomatic; Clinical trial; Phase II; GM-CSF; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Median Time to Treatment Termination (TTT)

  TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant.

  Up to 460 days

Secondary Outcomes (3)

• Median Time to Progression (TTP)

  Up to 60 months

• Tumor Response Rate (RR)

  Up to 60 months

• Number of Participants With Adverse Events (Toxicity) Grade 3 or 4

  Up to 460 days

Other Outcomes (1)

• Change From Baseline of Anti-Trag Antibodies

  Up to 60 months

Study Arms (2)

GM-CSF, Sargramostim Cohort 1

EXPERIMENTAL

GM-CSF, Sargramostim 250 μg/m\^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.

Drug: GM-CSF, sargramostim

GM-CSF, Sargramostim Cohort 2

EXPERIMENTAL

GM-CSF, sargramostim 150 μg/m\^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity fora median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m\^2 per day if applicable based on toxicity and white blood cell count.

Drug: GM-CSF, sargramostim

Interventions

GM-CSF, sargramostim DRUG

GM-CSF subcutaneous injection

Also known as: Leukine®

GM-CSF, Sargramostim Cohort 1; GM-CSF, Sargramostim Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a history of histologic or cytologic diagnosis of primary ovarian, primary peritoneal or tubal carcinoma.
• Patients must be asymptomatic from their cancer.
• Patients must have evidence of recurrent carcinoma, as determined by:
• A rising cancer antigen 125 (CA-125) serum level greater than 35 U/mL or two successive rising values with the most recent value at least 3 times the nadir value.
• Or evidence of evaluable or measurable disease by x-ray or computed tomography (CT) scan.
• Patients may not receive concurrent antineoplastic therapy. All hormonal therapy used as a treatment modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on protocol.
• Age \> 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \< 2.

You may not qualify if:

• Known severe hypersensitivity to GM-CSF.
• Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or concurrent superficial or stage IB endometrial carcinoma.
• Concomitant use of anti-neoplastic therapy.
• Treatment with a non-FDA approved or investigational drug within 30 days before Day 1 of trial treatment.
• Any unresolved chronic toxicity greater then Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy (except alopecia).
• Serum creatinine level greater than CTC grade 2 \[1.5 x upper limit normal (ULN)\].
• Pregnancy or breast feeding (women of childbearing potential).
• Severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator.
• Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate in the trial as judged by the investigator.
• Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment.
• Patients with clinical and/or radiographic evidence of current or impending bowel obstruction.
• Performance status \< 1.
• Ability to understand and the willingness to sign a written informed consent document.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Bayer: collaborator

Related Publications (1)

• Roche MR, Rudd PJ, Krasner CN, Matulonis UA, Berlin ST, Lee H, Silver M, Tran CD, Seiden MV, Penson RT. Phase II trial of GM-CSF in women with asymptomatic recurrent mullerian tumors. Gynecol Oncol. 2010 Feb;116(2):168-72. doi: 10.1016/j.ygyno.2009.10.075. Epub 2009 Nov 18.

  PMID: 19922985 RESULT

Related Links

• Sponsor information

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Richard T Penson MD MCCP
• Organization: MGH DF/HCC

rpenson@partners.org

617-726-8566

Study Officials

• Richard T Penson, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: April 1, 2010
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-03