Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers

NCT00319748 | Completed Phase 2 Results DMC

• 3 other identifiers: 06US03IMP-852AMT2006-022006LS005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.

Conditions

Breast Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer

Keywords

Breast; Ovarian; Endometrial; Cervical; Metastatic; 852A; IRM; Oncology; Metastatic Cervical Cancer; Metastatic Ovarian Cancer; Metastatic Breast Cancer; Metastatic Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.

  Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.

  after 12 weeks (24 doses of 852A)

Secondary Outcomes (6)

• Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)

  Prior to Dose 1 and 6 hours after Dose 1

• Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)

  Prior to Dose 1 and 6 Hours Post-Dose

• Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)

  Prior to Dose 1 and 6 Hours Post-Dose

• Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)

  Prior to Dose 1 and 6 Hours Post-Dose

• Mean Difference Values for Soluble CD40 Ligand (sCD40L)

  Prior to Dose 1 and 6 Hours Post-Dose

Study Arms (2)

Intent-To-Treat

EXPERIMENTAL

Patients treated with at least one dose - 852A subcutaneous injection.

Drug: 852A

Evaluable Cohort

EXPERIMENTAL

Patients who received all 24 doses of 852A per protocol.

Drug: 852A

Interventions

852A DRUG

0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.

Also known as: TLR-7, Toll-like receptor-7

Evaluable Cohort; Intent-To-Treat

Eligibility Criteria

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

You may qualify if:

• Adequate performance status:
• Breast - Karnofsky score \> 50;
• Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2
• If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.
• Normal organ function within 14 days of study entry
• Diagnosis of one of the following malignancies:
• Metastatic breast cancer (BR)
• Metastatic ovarian cancer (OV)
• Metastatic endometrial cancer (EM)
• Metastatic cervical cancer (CX)
• Measurable metastatic disease (\>1cm) in at least one site other than bone-only
• Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease
• Progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen.
• Measurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
• Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma).

You may not qualify if:

• Had/have the following prior/concurrent therapy:
• Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
• Investigational drugs/agents within 14 days of first dose of 852A
• Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
• Drugs known to induce QT interval prolongation and/or induce Torsades de pointes unless best available drug required to treat life-threatening conditions
• Radiotherapy within 3 weeks of the first dose of 852A
• Hematopoietic cell transplantation within 4 weeks of first dose of 852A
• Evidence of active infection within 3 days of first dose of 852A
• Active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable)
• Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
• History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
• Uncontrolled intercurrent or chronic illness
• Active autoimmune disease requiring immunosuppressive therapy within 30 days
• Active coagulation disorder not controlled with medication
• Pregnant or lactating

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• Pfizer: collaborator

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland 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; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Other Adverse Events that occurred were noted as targeted toxicities and not captured as adverse events.

Results Point of Contact

• Title: Melissa Geller, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

gelle005@umn.edu

612-626-3111

Study Officials

• Sarah Cooley, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

• Melissa A. Geller, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: August 26, 2019
• Results First Posted: September 25, 2009

Record last verified: 2019-08

Locations

US (1)