Behaviors and Mental Disorders

All Conditions

Quality of Life

Andrea Cuviello, MD, FAAP

Lori Wiener, PhD

This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Palliative care (PC) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of PC into the care of patients enrolled on experimental clinical trials.

Primary Objective

* To qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a Phase I clinical trial.

Eligible Parent Research Participants (PRPs) who consent will participate in one audio recorded interview in which they are asked about 8-10 questions. The interview can be conducted in person, over the phone, or WebEx/Zoom (audio only). The interview will last about 30 to 60 minutes. PRPs can opt to complete interviews immediately or at a scheduled date that is convenient to the PRP.

Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients

Qualitative analysis of interviews done with parents of children with cancer who are enrolling in phase 1 studies will be performed. Broad thematic domains will be identified through a rigorous review of transcript data, with the development of codes to delineate conceptual categories. Domains will be further sub-stratified as text analysis progresses in order to identify new themes and formulate new concepts and theories. To enhance construct validity and reliability of identified domains, data will be audited by an expert panel of PPC investigators with proficiency in communication-based research, including both clinicians and researchers. Coding schemata will remain flexible to accommodate expansion of the list as the PI and expert panel agree on new code additions. Following the well-described processes of disassembling and reassembling coding categories, emerging themes will be categorized and refined, with the ultimate goal of theory-building.

St. Jude Children's Research Hospital

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Renal Cell

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Interferon-alpha

Interferon alpha-2

Antimony Sodium Gluconate

Antiviral Agents

Immunologic Factors

Antiprotozoal Agents

Antiparasitic Agents

Anthelmintics

Sodium Stibogluconate (SSG) 400 mg/m\^2 intravenous (IV) daily on days 1-5 + Interferon Alfa-2b (Intron A) 3x10\^6 units subcutaneously three times weekly

Sodium Stibogluconate

3x10\^6 units subcutaneously three times weekly

Interferon Alpha-2b

Aung Naing, MD

Primary Objective:

-To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies.

Secondary Objectives:

* To correlate the AUC of SSG with clinical toxicity and efficacy.
* To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal transduction pathways.
* To characterize the effects of SSG on PTPases SHP-1 and SHP-2.
* To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.

Sodium stibogluconate is a drug that is able to block an enzyme in the cells that is responsible for cell growth. By blocking this enzyme, it may be able to prevent cancer cells from multiplying.

Interferon alfa-2b is a drug that activates an immune response to infections in the body. By triggering an immune response, this drug may help to prevent some cancer cells from growing and multiplying. You will receive treatment with both sodium stibogluconate and interferon alfa-2b, because sodium stibogluconate may improve the effectiveness of interferon in treating the cancer.

Participants will be enrolled in groups of 3 on this study, and the doses of the study drugs will be escalated for each group. This means that each new group of 3 participants will get a higher dose of the study drugs than the group before them. This will continue until the highest tolerable dose combination is found.

Once the highest tolerable dose has been found, up to an additional 9 participants, called the expansion group, will receive study drug at that dose. Your doctor will tell you if you are in the expansion group.

If you are found to be eligible to take part in this study, you will go to the clinic to start treatment. During Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5. On Days 8-12, you will be given sodium stibogluconate once a day by vein, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 8, 10, and 12. For every cycle after Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5 and 8-12, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 1, 3,5, 8, 10, and 12. Treatment cycles will last about 3 weeks (2 weeks on treatment, followed by 1 week off treatment).

During each visit to the clinic, you will be asked how you are feeling, and your vital signs will be measured. You will have a complete physical exam the first day of every cycle. On Days 1, 8, and 12 of every cycle, you will have a urine test to check the function of your kidneys, and blood (about 3 teaspoons) will be drawn for routine tests. On Days 1, 8, and 12 of every cycle and during your last study visit, you will have an additional blood draw (about 5 teaspoons) for immunological testing (to help researchers learn how your body fights disease) before treatment. On Days 1, 5, 8, and 12 of every cycle, you will have an ECG after you receive treatment.

At some time during the week before Day 1 of Cycle 1 and on Day 12 of Cycle 2, you may have a tumor biopsy to check the status of the disease before you receive the study drug. To perform a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tumor tissue is withdrawn through a large needle. Your doctor will tell you if this may be necessary.

On Days 1, 2, 9, 12, and 13 of Cycle 1, you will have blood drawn (about 1 teaspoon each) for PK testing. On Days 1, 8, and 12, the PK testing will be done before, 30 minutes after, and 2 hours after you receive the study drug. On Days 2 and 9, the PK testing will be done before treatment. On Day 13, the PK testing will be done 24 hours after you received treatment on Day 12.

After Cycle 1, you will be scheduled to return to the clinic in 10 days to receive treatment for Cycle 2, which will follow in the same manner as Cycle 1.

At the end of Cycle 2 and every even-numbered cycle (Cycles 4, 6, 8, and so on) after that, you will have imaging studies, such as x-rays and CT scans, to check the status of your tumors.

If the disease does not get worse and you do not experience any intolerable side effects after Cycle 1, you will continue on to Cycle 2, and so on. If at any time the disease gets worse or you experience any intolerable side effects, you will be taken off this study.

This is an investigational study. Sodium stibogluconate is not FDA approved or commercially available. It is authorized for use in research only. Interferon alfa-2b is approved by the FDA for the treatment of some types of cancers (solid tumors). The combination of these drugs is investigational in this study. Their use together is authorized for use in research only.

However, if sodium stibogluconate becomes commercially available while you are still on study. Up to 54 patients will take part in this multicenter study. Up to 35 will be enrolled at M. D. Anderson.

Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sodium Stibogluconate in Combination With Interferon Alpha-2b for Patients With Advanced Malignancies

MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs.

VioQuest Pharmaceuticals

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients	NCT05412563	Quality of Life		18 Years -	St. Jude Children's Research Hospital
Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients	NCT05412563	Quality of Life		18 Years -	St. Jude Children's Research Hospital
Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies	NCT00629200	Advanced Cancer Solid Tumors	Sodium Stiboglu... Interferon Alph...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for phase i studies