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A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alemtuzumab

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have a diagnosis of histologically confirmed ovarian, fallopian or primary peritoneal cancer that has progressed or recurred in the abdomen or pelvis after salvage chemotherapy as documented by either:
1. Radiologic studies or
2. Rising CA125 levels on two independent measurements. If the patient's CA125 has fallen into a normal range, CA125 relapse will be defined as double the nadir CA125. However, if the patients CA125 nadir had fallen to less than 10, then the measurements documenting recurrence or progression must be greater than 20.
There is no limit on prior courses of chemotherapy.
Patients must have unidimensional measurable disease or elevated CA125
Age greater than 18 years.
ECOG performance status less tha 2 (Karnofsky 60%).
Life expectancy of greater than 12 weeks.
Patients must have adequate organ and marrow function
Ability to understand and the willingness to sign a written informed consent document. All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.
Timing guideline for pre-study labs and measurements:

All pre-study labs required for determination of eligibility are to be completed within 28 days of treatment Day 1.

X-rays and/or scans used for tumor measurement to determine disease status are to be completed within 28 days of treatment Day 1.

Women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

Patients with known immunosuppressive diseases are excluded from this trial due to the known immunosuppressive nature of Alemtuzumab therapy.
Patients may not be receiving any other agents (investigational or otherwise) with therapeutic intent.
Patients with prior malignancy, except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years.
Patients with a history of allergic reactions to Alemtuzumab or other humanized immunotherapeutics.
Patients with unresolved bacterial, fungal, or viral infections requiring active treatment. Patients may be registered two weeks after the conclusion of antibiotic or anti-viral therapy.
Patients with history of active CMV disease as Alemtuzumab therapy has been associated with CMV reactivation.

Sites / Locations

University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one

Arm Description

Outcomes

Primary Outcome Measures

safety & maximally tolerated dose

Secondary Outcome Measures

Effectiveness of Alemtuzumab to eliminate VLCs.

Assess molecular markers associated with reduction in VLCs.

Anti-tumor activity measured by decline or stabilization of CA125(a protein that is a tumor marker)or radiological(ie. CT, MRI, X-Ray)improvement or improvement in progression free survival.

Alemtuzumab effect on patients' response rates to chemotherapy given after the discontinuation of chemotherapy.

Full Information

NCT ID

NCT00637390

First Posted

March 10, 2008

Last Updated

December 1, 2016

Sponsor

University of Michigan Rogel Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00637390

Brief Title

A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.

Official Title

A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Terminated

Why Stopped

Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame.

Study Start Date

March 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Ovarian cancer cannot grow without recruiting new blood vessels. Studies in humans have identified a novel cell population, termed vascular leukocytes (VLCs). While VLCs are not cancer cells, they support the growth of ovarian cancer cells by stimulating the growth of new blood vessels which provide the cancer with nutrients. VLCs make a protein termed CD52. An antibody therapeutic, Alemtuzumab (also know as Campath), that kills cells that make the CD52 protein has been successfully used to treat certain lymphomas (a type of blood cell cancer) that make CD52 protein. The purpose of this study is to determine if Alemtuzumab given subcutaneously (under the skin)can be safely given to patients with ovarian, fallopian, or primary peritoneal cancers to kill VLCs and determine if Alemtuzumab, by eliminating VLCs, can restrict tumor growth or increase response rates to chemotherapy given after the discontinuation of chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

one

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Alemtuzumab

Intervention Description

will be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks

Primary Outcome Measure Information:

Title

safety & maximally tolerated dose

Time Frame

Maybe 2 years

Secondary Outcome Measure Information:

Title

Effectiveness of Alemtuzumab to eliminate VLCs.

Time Frame

Maybe 2 years

Title

Assess molecular markers associated with reduction in VLCs.

Time Frame

Maybe 2 years

Title

Anti-tumor activity measured by decline or stabilization of CA125(a protein that is a tumor marker)or radiological(ie. CT, MRI, X-Ray)improvement or improvement in progression free survival.

Time Frame

Maybe 2 years

Title

Alemtuzumab effect on patients' response rates to chemotherapy given after the discontinuation of chemotherapy.

Time Frame

Maybe 2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have a diagnosis of histologically confirmed ovarian, fallopian or primary peritoneal cancer that has progressed or recurred in the abdomen or pelvis after salvage chemotherapy as documented by either: Radiologic studies or Rising CA125 levels on two independent measurements. If the patient's CA125 has fallen into a normal range, CA125 relapse will be defined as double the nadir CA125. However, if the patients CA125 nadir had fallen to less than 10, then the measurements documenting recurrence or progression must be greater than 20. There is no limit on prior courses of chemotherapy. Patients must have unidimensional measurable disease or elevated CA125 Age greater than 18 years. ECOG performance status less tha 2 (Karnofsky 60%). Life expectancy of greater than 12 weeks. Patients must have adequate organ and marrow function Ability to understand and the willingness to sign a written informed consent document. All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines. Timing guideline for pre-study labs and measurements: All pre-study labs required for determination of eligibility are to be completed within 28 days of treatment Day 1. X-rays and/or scans used for tumor measurement to determine disease status are to be completed within 28 days of treatment Day 1. Women of all races and ethnic groups are eligible for this trial. Exclusion Criteria: Patients with known immunosuppressive diseases are excluded from this trial due to the known immunosuppressive nature of Alemtuzumab therapy. Patients may not be receiving any other agents (investigational or otherwise) with therapeutic intent. Patients with prior malignancy, except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years. Patients with a history of allergic reactions to Alemtuzumab or other humanized immunotherapeutics. Patients with unresolved bacterial, fungal, or viral infections requiring active treatment. Patients may be registered two weeks after the conclusion of antibiotic or anti-viral therapy. Patients with history of active CMV disease as Alemtuzumab therapy has been associated with CMV reactivation.

Facility Information:

Facility Name

University of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.

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