Neoplasms

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Nervous System Neoplasms

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Female Urogenital Diseases and Pregnancy Complications

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IV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle.

IV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle. Up to 7 dose levels will be tested, starting with 0.05 microequivalents per kg and up to 2.5 microequivalents per kg.

IGF-Methotrexate conjugate

Neeta Venepalli, MD

This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient refusal. Assessment of response will be confirmed with imaging studies performed at the end of cycle 2 +/- 7 days, and every 2 weeks thereafter.

Study of Insulin-like Growth Factor (IGF)-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R

STM-02: Phase I Study of IGF-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing Insulin-like Growth Factor Receptor 1 (IGF-1R)

The primary objective is to determine the maximum tolerated dose (MTD) of 765IGF-MTX by evaluation of toxicity for the treatment of advanced, previously treated malignancies that express IGF-1R.

Characterize adverse effects (AE) of 765IGF-MTX in patients with advanced, previously treated malignancies as defined by CTCAE v 4.0.

Evaluate clinical response of 765IGF-MTX in patients with advanced, previously treated malignancies. Disease response will be assessed every 8 weeks while on study treatment using the Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).

IGF Oncology, LLC

Urinary Bladder Neoplasms

Patients will receive standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment.

Patients will receive additional education with standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients will also be asked to complete an attendance diary documenting additional support services utilized. The Attendance Diary will be completed at 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment.

Study-Specific Patient Handouts, Treating-Provider led counseling, Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and referrals for additional support services

Additional Education

Female Sexual Function Index, Demoralization Scale-II

Questionnaires

Attendance Diaries for the Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and additional educational and support services utilized

Attendance Diary

Meghan McNamara

Armine Smith

Riziki Covington

Armine Smith, MD

Armine K Smith

This research is being done to learn more about coping and survivorship of women with bladder cancer, specifically regarding psychosocial distress and sexual dysfunction. This study is a non-therapeutic study and will randomize participants to a standard of care group and education group. Patients in both groups will be asked to complete surveys regarding their mood and sexual function. Patients in the intervention group will be asked to complete attendance diaries regarding educational and support services utilized. Participants' clinical data will also be collected.

The Gender Related Coping and Survivorship Study for Genitourinary Cancers is focused on providing patients with additional education to promote sexual function in female bladder cancer patients with the aim to help decrease demoralization and sexual dysfunction. Patients receiving a cystectomy and patients not receiving a cystectomy will be randomized separately into an additional education or standard of care group. The additional education consists of asking patients to attend the Women and Bladder Cancer Educational Series, Women's Bladder Cancer Support Group meetings, referrals to other support services, receiving supplemental handouts and treating physician led counseling incorporated into standard of care visits. All participants will be asked to complete the Demoralization Scale-II and Female Sexual Function Index at baseline, one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment. Patients randomized to the additional education group will also be asked to complete an attendance diary one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment.

Gender Related Coping and Survivorship for Genitourinary Cancers

Evaluate educational interventions to improve demoralization in females with bladder cancer. The minimum score is 0 and the maximum score 32. Low scores are defined as 0-3, middle scores are defined between 4-10, and high scores are defined as ≥11.

Evaluate if educational interventions improve sexual function in females with bladder cancer. The minimum total score for the FSFI is 2 and the maximum total score is 36. A higher score indicates increased sexual function.

Assess how coping in females with bladder cancer differs by stage of bladder cancer. For the Demoralization Scale II, the minimum score is 0 and the maximum score 32. Low scores are defined as 0-3, middle scores are defined between 4-10, and high scores are defined as ≥11.

Assess how coping in females with bladder cancer differs by stage of bladder cancer. The minimum total score for the FSFI is 2 and the maximum total score is 36. A higher score indicates increased sexual function.

Assess survivorship in females with bladder cancer differs by stage of bladder cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Insulin-like Growth Factor (IGF)-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R	NCT02045368	Breast Cancer Brain Cancer Gastrointestina... Genitourinary C... Gynecologic Can... Head and Neck C... Melanoma Thoracic Cancer...	IGF-Methotrexat...	18 Years -	IGF Oncology, LLC
Gender Related Coping and Survivorship for Genitourinary Cancers	NCT05649306	Bladder Cancer	Additional Educ... Questionnaires Attendance Diar...	18 Years -	Johns Hopkins University
Study of Insulin-like Growth Factor (IGF)-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R	NCT02045368	Breast Cancer Brain Cancer Gastrointestina... Genitourinary C... Gynecologic Can... Head and Neck C... Melanoma Thoracic Cancer...	IGF-Methotrexat...	18 Years -	IGF Oncology, LLC
Gender Related Coping and Survivorship for Genitourinary Cancers	NCT05649306	Bladder Cancer	Additional Educ... Questionnaires Attendance Diar...	18 Years -	Johns Hopkins University
Study of Insulin-like Growth Factor (IGF)-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R	NCT02045368	Breast Cancer Brain Cancer Gastrointestina... Genitourinary C... Gynecologic Can... Head and Neck C... Melanoma Thoracic Cancer...	IGF-Methotrexat...	18 Years -	IGF Oncology, LLC

Spots Global Cancer Trial Database for genitourinary cancers