← Back to Search

Monoclonal Antibodies

Monoclonal Antibody Therapy for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by AltaRex

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status: ECOG 0-2 Karnofsky 60-100%

Residual disease (visible or palpable) at completion of the staging laparotomy (IIIB and IIIC microscopic disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether monoclonal antibody therapy can kill residual cancer cells in patients with ovarian, fallopian tube, or peritoneal cancer who have responded to surgery and chemotherapy.

Who is the study for?

This trial is for adults over 18 with stage III or IV ovarian, fallopian tube, or peritoneal cancer who've had surgery and chemo. They should have some remaining disease after surgery, be in good physical shape (ECOG 0-2 or Karnofsky 60-100%), and have certain blood cell counts within specific ranges. People can't join if they've had recent other treatments like immunotherapy, more than one chemotherapy regimen, radiotherapy to the abdomen/pelvis area, multiple surgeries, or prior murine monoclonal antibodies.Check my eligibility

What is being tested?

The study is testing whether monoclonal antibody therapy works better than a placebo for patients with residual cancer following initial treatment. It's a phase II trial where participants are randomly assigned to receive either the new antibody treatment or a placebo to compare effectiveness.See study design

What are the potential side effects?

Monoclonal antibodies may cause allergic reactions and might target normal cells leading to side effects which could include fever, chills, weakness, nausea/vomiting; however exact side effects will depend on the specific type of antibody used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and perform daily activities.

Select...

I still have visible or palpable cancer after initial surgery.

Select...

I am 18 years old or older.

Select...

My CA 125 levels were high before or at the time of my surgery.

Select...

My ovarian, tubal, or peritoneal cancer responded completely to initial treatment.

Select...

My bilirubin levels are not more than 1.5 times the normal upper limit.

Select...

My creatinine level is 1.6 mg/dL or lower.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

AltaRexLead Sponsor

1 Previous Clinical Trials

102 Total Patients Enrolled

1 Trials studying Ovarian Cancer

102 Patients Enrolled for Ovarian Cancer

Jonathan S. Berek, MDStudy ChairJonsson Comprehensive Cancer Center

2 Previous Clinical Trials

2 Trials studying Ovarian Cancer

Media Library

Monoclonal Antibody Therapy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00003634 — Phase 2

Ovarian Cancer Clinical Trial 2023: Monoclonal Antibody Therapy Highlights & Side Effects. Trial Name: NCT00003634 — Phase 2

Monoclonal Antibody Therapy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003634 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks do patients face when undergoing this procedure?

"Our team at Power assigned a safety rating of 2 to this treatment due to its Phase 2 status, indicating the presence of some evidence for safety but no data supporting efficacy."

Answered by AI

How many locations are involved with the management of this clinical trial?

"In total, 46 medical centres are enrolling patients in this trial. For example, Edmonton's Cross Cancer Institute and Montreal's Centre Hospitalier de l'Universite de Montreal have already begun the recruitment process as has California's Chao Family Comprehensive Cancer Center."

Answered by AI

Is the enrollment phase for this trial still open?

"According to clinicialtrials.gov, this medical trial is not currently accepting candidates. It was first announced on April 1st 1998 and its records were last updated November 5th 2013; however, 496 other clinical trials are available for potential participants right now."

Answered by AI