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Ovarian CancerPhase 2NCT00157573

GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

A Phase 2 study testing GM-CSF, sargramostim in people with Ovarian Cancer and Fallopian Tube Cancer, run by Massachusetts General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Fallopian Tube Cancer
What is being tested?
GM-CSF, sargramostim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
No sites listed yet
Study dates
Dec 2004to Apr 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)].
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  • 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.

About this study

Official title: Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

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.

Read the detailed description

This is an open labeled, single arm phase II study of GM-CSF, sargramostim delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). The main goal is to determine the time to treatment termination due to disease progression or toxicity.

Being tested
GM-CSF, sargramostim
Keywords
Asymptomatic, Clinical trial, Phase II, GM-CSF, Immunotherapy
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GM-CSF, sargramostimDrug

    Also called Leukine®

    GM-CSF subcutaneous injection

Study groups in NCT00157573
Study groupRoleWhat they receive
GM-CSF, Sargramostim Cohort 1ExperimentalGM-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.
Receives: Drug: GM-CSF, sargramostim
GM-CSF, Sargramostim Cohort 2ExperimentalGM-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.
Receives: Drug: GM-CSF, sargramostim

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 460 days

Secondary outcomes (3)

  1. Median Time to Progression (TTP)

    TTP was defined as the median time in days from trial entry until progressive disease (PD) was documented as defined by RECIST criteria. PD was defined of at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In participants with no measurable disease who had an informative cancer antigen-125 (CA-125), PD was defined as a rise of > 50% over Baseline, confirmed by a subsequently higher value at least 21 days later.

    Measured: Up to 60 months

  2. Tumor Response Rate (RR)

    RR is the percentage of patients with response as assessed by the investigator using Response Evaluable Criteria in Solid Tumors (RECIST) and CA-125 Rustin criteria. Complete Response (CR) is the disappearance of all target and non-target lesions and normalization of CA-125. Partial Response (PR) is at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; in patients with no measurable disease with an informative CA-125, the 75% definitions by Rustin is used. Stable Disease is neither sufficient shrinkage for PR nor increase for PD, taking as reference the smallest sum LD since the treatment start. PD is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start or the appearance of one or more new lesions; in patients with no measurable disease with an informative CA-125, PD is defined as a rise of > 50% over baseline, confirmed by a higher value 21 days later.

    Measured: Up to 60 months

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

    Adverse Events (previously toxicity) were graded according the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The total number of participants with adverse events graded 3 (severe) or 4 (life-threatening or disabling) are reported.

    Measured: Up to 460 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionOct 2008
  4. Study completionApr 2010

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00157573
Sponsor's protocol ID
04-305
Status last verified
Mar 2017
First submitted
8 Sep 2005
Last updated
8 May 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 19922985

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GM-CSF, sargramostim in people with Ovarian Cancer and Fallopian Tube Cancer, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. 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 8 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Median Time to Treatment Termination (TTT) (time frame: Up to 460 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00157573, which also lists 1 linked publication.

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 8 May 2017.

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