Neoplasms

All Conditions

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Vincristine

3-Iodobenzylguanidine

Enzyme Inhibitors

Radiopharmaceuticals

The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.

The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.

Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42.

Metaiodobenzylguanidine (MIBG)

Steven DuBois, M.D.

This is a pilot study to determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are tolerable when given with irinotecan/vincristine on a one week schedule to children and young adults with high-risk refractory/relapsed neuroblastoma.

131I-metaiodobenzylguanidine (131I-MIBG) is an active therapy in patients with widely metastatic, treatment-resistant neuroblastoma, where response rates are 20-40% at doses (\> 15mCi/kg) requiring stem cell rescue. Irinotecan is a topoisomerase I inhibitor with single-agent chemotherapeutic activity against neuroblastoma and other pediatric solid tumors in phase I and II clinical trials. With more protracted schedules (e.g. daily for 5 days/week x 2 weeks), the major dose-limiting toxicity is diarrhea. With shorter schedules, myelosuppression becomes dose-limiting. In adult solid tumors, irinotecan has been an effective radiosensitizer and is currently being evaluated by the Children's Oncology Group for this purpose in rhabdomyosarcoma protocols incorporating external beam radiotherapy.

Compared to single-agent 131I-MIBG, the combination of topotecan (a related camptothecin) and 131I-MIBG demonstrated superior pre-clinical activity in mouse xenograft models of neuroblastoma. This combination had no unexpected toxicities in a pilot clinical study. We have completed a clinical trial of vincristine, irinotecan, 131I-MIBG that utilized irinotecan on a protracted schedule (5 days per week x 2 weeks). The rationale for this schedule was to provide a greater degree of overlap between the radiation sensitizer (irinotecan) and the radiation exposure provided following 131I-MIBG infusion. This combination was shown to be tolerable at doses up to 18 mCi/kg 131I-MIBG. However, more patients experienced grade 2 and 3 diarrhea than would be customary with the dose and schedule of irinotecan used in that trial. It is therefore of interest to determine whether this combination of irinotecan, vincristine, and 131I-MIBG will be better tolerated using irinotecan at higher doses in a shorter schedule. The current standard schedule in Children's Oncology Group protocols for the combination of vincristine, irinotecan is now a higher dose in five, rather than 10 days. In the current pilot study, we will evaluate the tolerability and anti-tumor activity of this combination using irinotecan given once daily for 5 days only. Two 131I-MIBG dose levels will be evaluated. This study will provide the basis for a future randomized trial.

High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed Neuroblastoma

Pilot Study of High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed High-Risk Neuroblastoma

To determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are tolerable when given with irinotecan/vincristine on a 5-day schedule to children and young adults with high-risk refractory/relapsed neuroblastoma.

Therapeutic response rate to regimen according to the NANT modified-version of the International Neuroblastoma Response Criteria.

Rate of protocol associated diarrhea according to UGT1A1 genotype.

To describe changes in standardized uptake values (SUVs) obtained by 18FDG-PET scan at study entry and in response to one cycle of protocol therapy.

Thrasher Research Fund

University of California, San Francisco

Assistant Professor of Pediatrics

The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.

Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42.

15 mCi/kg of 131I-MIBG

The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.

Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42.

18 mCi/kg of 131I-MIBG

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Steven DuBois, MD

Number of Participants With Dose-limiting Toxicity as a Measure of Tolerability

Therapeutic Response Rate

Diarrhoea (any grade)

Diarrhoea (> grade 2)

Wildtype population, no UGT1A1 polymorphisms

Homozygous Wildtype

Population Heterozygous for UGT1A1\*28 polymorphisms

Heterozygous UGT1A1*28 Genotype

Population homozygous UGT1A1\*28 genotype polymorphisms

Homozygous UGT1A1*28 Genotype

Changes in Diarrhea

No PET scans were performed during this trial.

Changes in Standardized Uptake Values on FDG-PET Scans

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Aggression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Personalized risk model+website+phone coaching

A health coach (members of the Patient Support Corps at the University of California San Francisco) will contact each subject individually to discuss his tailored/personalized web-portal report on his risk of aggressive disease and the pro/cons of treatment versus active surveillance.

The contact between subject and the health coaches will be done before subject's visit with his primary urologist. Subjects will be asked to complete different questionnaires on four different occasions: one at first visit to the interactive secure web portal; one before coach's call; one after the coaching (after the urologist visit), and one at 6 months. The questionnaire after subject's visit with the urologist includes discussion about their management choice, decision quality, anxiety and satisfaction with care.

Personalized risk model+website+coaching intervention

Peter Carroll, MD, MPH

A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and uncertainty, thereby increasing appropriate uptake of active surveillance and reducing over-treatment of low-risk prostate cancer.

This study involves: completion of questionnaires through the secure website; consultation by a health coach to aid men with prostate cancer in making informed treatment decision (personalized coaching session(s)).

A UCSF PI-initiated study which includes comprehensive decision support intervention that may incorporate clinical, lifestyle, tumor genomic, and germline gene variant data.

The web and coaching intervention will: 1) summarize key prognostic data elements, 2) communicate relative and absolute risks of upgrading/upstaging based on each of these elements, individually and in aggregate, and 3) provide tailored educational information for informed decision making on treatment options. A key aspect of the intervention will be provision of tiered coaching to the men prior to their physician visits to help them enter information accurately into the system, understand the results of the prediction model, document their questions for their physicians, and prepare them to make better-informed treatment decisions. UCSF research team will develop the decision support intervention in phases, initially using only clinical variables, BMI (body mass index), and smoking data;and then extend it to include information from genomic and genetic inputs, as validation work progresses. Variables will be retained based on statistical evaluation of the predictive values.

Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model

Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive vs Indolent Prostate Cancer (Aim 2A)

measured using the Decision Quality Index

Measured using Decision Self-Efficacy survey

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Paragangliomas 1

Neuroendocrine Tumor

Patients received 131I-MIBG 8-12 mCi/kg (maximum 500 mCi ± 10% at investigator's discretion) diluted in 25 ml of normal saline. Patients were infused intravenously through a patient's peripheral or central line over 120 minutes

Therapeutic 131I-MIBG will be synthesized at Nuclear Diagnostic Products (NDP; Rockaway, New Jersey) with specific activities of 9-18 Ci/mmole. The therapeutic dose: 8-12 mCi/kg (maximum 1200 mCi ± 10% at investigator's discretion) will be diluted in 25 ml of normal saline, and will be infused intravenously through a patient's peripheral or central line over 120 minutes. The patient will remain in a radiation protected isolation room until radiation emissions are ≤ 2 mr/hr at a 1 meter distance or meets institutional and state guidelines. This usually takes 4-6 days. In all cases, special shielding will be equipped in the room to minimize exposure to the outside environment and personnel will observe institutional radiation safety precautions.

131I-MIBG

Paul Fitzgerald

This is an ongoing prospective Phase II clinical trial evaluating the efficacy of 131I-MIBG for the treatment of patients with metastatic or unresectable pheochromocytoma and related tumors.

1. To assess the efficacy of high-dose 131I-MIBG in the treatment of patients with malignant pheochromocytoma and related tumors, with the basis of this initial examination being the percentage of patients in CR or PR, and the percentage of patients without PD for 3 years after the initial administration on 131I-MIBG therapy.
2. To describe the response rate of malignant pheochromocytoma patients treated with high-dose 131I-MIBG.
3. To describe the toxicity of high-dose 131I-MIBG in patients with malignant pheochromocytoma.
4. To describe the overall survival and failure-free survival of malignant pheochromocytoma patients treated with high-dose 131I-MIBG.
5. To determine the utility of using the serum level of Chromogranin A as a tumor marker for patients with malignant pheochromocytoma.

A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors

A Phase II Study of 131I-labeled Metaiodobenzylguanidine (MIBG) for Treatment of Patients With Metastatic or Unresectable Pheochromocytoma and Related Tumors

Patients with complete (CR), partial (PR), or minor (MR) response and without progressive disease 1 year from initial treatment, using RECIST RESPONSE CRITERIA for measurable soft tissue tumor: CR=No Tumor (Primary or metastatic); catacholamines, metanephrines and chromogranin A all normal. PR=Primary and all measurable sites decreased \>50%; number of positive bone sites decreased by \>50%; bone marrow tumor decreased by 50%. MR=No new lesions; \>50% reduction of any measurable lesion (primary or metastases); \<25% increase in any existing lesion.

All study records, including participant charts, IND files, and staff computers, were destroyed in a flood. Partial Adverse Event information was derived from publication-PubMed ID: 19636009

Patients received 131I-MIBG infused intravenously through a peripheral or central line over 120 minutes.

Of 50 patients enrolled and treated, one patient was lost to follow-up.

All study data were destroyed in a flood after study completion and prior to results posting in ClinicalTrials.gov. Partial Adverse Event information was derived from publication-PubMed ID: 19636009

Paul A. Fitzgerald, MD

Patients received 131I-MIBG infused intravenously through a peripheral or central line over 120 minutes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed Neuroblastoma	NCT01313936	Neuroblastoma	Metaiodobenzylg...	1 Year - 30 Years	University of California, San Francisco
High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed Neuroblastoma	NCT01313936	Neuroblastoma	Metaiodobenzylg...	1 Year - 30 Years	University of California, San Francisco
Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model	NCT02451345	Prostate Cancer	Personalized ri...	18 Years -	University of California, San Francisco
A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors	NCT01413503	Pheochromocytom... Paraganglioma	131I-MIBG	4 Years -	University of California, San Francisco
A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors	NCT01413503	Pheochromocytom... Paraganglioma	131I-MIBG	4 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for ucsf

Every month we try and update this database with for ucsf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ucsf

Every month we try and update this database with for ucsf cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ucsf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.