Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Endometrial Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

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

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

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.

852A

Sarah Cooley, MD

Melissa A. Geller, MD

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.

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.

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

Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers

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.

Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.

Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.

Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.

Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.

Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.

Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.

Pfizer

Masonic Cancer Center, University of Minnesota

Melissa Geller, M.D.

Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.

Patients that received at least one dose of study treatment with 852A (0.6 mg/m\^2 to 1.2 mg/m\^2 dose, 2 times/week for 12 weeks).

Patients Treated With 852A Study Drug

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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

Complete Response

Partial Response

Stable Disease

Progressive Disease

Participants with ovarian cancer who received all 24 doses of 852A.

Patients With Ovarian Cancer

Includes only patients that received all 24 doses of 852A.

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

Difference in range values from pre-treatment to post-treatment for cytokine level of IL1ra in patients treated with 852A.

Patients Treated With 852A

One patient did not have value reported at 6 hours after treatment, so cannot be included.

Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)

Difference in range values from pre-treatment to post-treatment for cytokine level of IP-10 in patients treated with 852A.

One patient did not have a value reported at 6 hours after treatment so cannot be included in analysis.

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

Difference in range values from pre-treatment to post-treatment for Macrophage Inflammatory Protein-1 Alpha (cytokine) level in patients treated with 852A.

Only 5 patients had a value reported at 6 hours after treatment.

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

Difference in range values from pre-treatment to post-treatment for cytokine level of MIP-1b in patients treated with 852A.

Two patients did not have recorded values at 6 hours after treatment so cannot be included in analysis.

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

Difference in range values from pre-treatment to post-treatment for cytokine level of sCD40L in patients treated with 852A.

One patient did not have recorded value at 6 hours after treatment and cannot be included in analysis.

Mean Difference Values for Soluble CD40 Ligand (sCD40L)

Difference in range values from pre-treatment to post-treatment for cytokine level of TNF-a in patients treated with 852A.

Only 9 patients had recorded values at 6 hours after treatment and were included in analysis.

Spots Global Cancer Trial Database for Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers

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