Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Natriuretic Agents

Anticonvulsants

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Acetazolamide

Furosemide

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Carbonic Anhydrase Inhibitors

Enzyme Inhibitors

Participants will receive chemotherapy to prepare your body for the study drug combination, then you will receive OBX-115 and acetazolamide.

OBX-115

Fludarabine Phosphate

Rodabe N Amaria, MD

The goal of this clinical research study is to find the recommended dose of OBX-115 in combination with acetazolamide that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors. The safety and tolerability of the study drug combination will also be studied.

Primary Objective:

• Assess the safety and tolerability of OBX-115 + acetazolamide by CTCAE version 5 criteria to provide a recommended Phase II dose

Secondary Objectives:

* Assess preliminary efficacy of OBX-115 + acetazolamide cell therapy in patients with immune checkpoint inhibitor (ICI)-relapsed and/or refractory metastatic melanoma by evaluating overall response rate (ORR; complete response \[CR\] + partial response \[PR\]) by RECIST 1.1 criteria
* Evaluate feasibility of the manufacturing process
* Evaluate duration of response (DOR)
* Evaluate progression free survival (PFS)
* Characterize in vivo cellular kinetics of OBX-115 cells in tumor and/or in peripheral blood by polymerase chain (PCR) and/or fluorescence-activated cell sorting (FACS) analyses
* Characterize the pharmacokinetic profile of acetazolamide when administered in combination with OBX-115
* Characterize the incidence and prevalence of OBX-115 therapy immunogenicity

Exploratory Objectives:

* Assess relationship of soluble immune factors and pharmacodynamic markers, with cellular kinetics, safety, and efficacy
* Describe the composition of OBX-115 subsets (immunophenotyping in peripheral blood mononuclear cells \[PBMCs\] and in tumor), summarized by clinical response
* Explore the correlation of OBX-115 kinetics in tumor and peripheral blood with clinical endpoints
* Explore the correlation of immune checkpoints with OBX-115 cellular kinetics and efficacy
* Evaluate overall survival (OS)

Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma

M.D. Anderson Cancer Center

Symptoms and General Pathology

Recurrence

Glioma

Glioblastoma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Temozolomide

Subjects will receive daily ACZ together with TMZ in 28 day cycles for up to 6 cycles if they do not experience either disease worsening or unacceptable side effects.

ACZ will be given at an initial dose of 250 mg twice a day (BID) and then escalated to 500 mg BID after 1 week. ACZ will be given on days 1-21 of each cycle.

For cycle 1 of the maintenance phase, TMZ will administered at 150 mg/m2 on days 1- 5 followed by 23 days with no drug. For cycles 2- 6, TMZ can be increased to 200 mg/m2 at the discretion of the treating investigator.

Bakhtiar Yamini, M.D.

Bakhtiar Yamini, MD

This is a Phase I study that examines the rate of dose limiting side effects in patients with malignant astrocytoma treated with combination acetazolamide (ACZ) and temozolomide (TMZ). Eligible patients must have histologically proven newly diagnosed, O6-methylguanine-DNA methyltransferase (MGMT) methylated WHO grade III or IV astrocytoma and be planning to undergo treatment with standard adjuvant TMZ (after completing treatment with TMZ and ionizing radiation (IR)).

During this study, patients will receive daily oral ACZ with TMZ. During each cycle, ACZ will be started on the day of TMZ initiation and continued for a total of 21 days.

Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma

A Phase I Study of Safety and Tolerability of Acetazolamide With Temozolomide in Adults With Newly Diagnosed MGMT Promoter-Methylated IDH Wildtype Glioblastoma

To determine the safety, tolerability and adverse event profile of adding acetazolamide to temozolomide in patients with newly diagnosed malignant astrocytoma.

ORR will be determined at 6 months and is based on the change in tumor size (as determined by Response Assessment in Neuro-Oncology Criteria (RANO) criteria) at the indicated time relative to the pre-treatment scan. RANO criteria will also be used to define disease status (CR, PR, etc.).

Bcl-3 expression will be determined by an independent neuro-pathologist by immunohistochemical analysis of formalin fixed paraffin embedded (FFPE) surgical specimens. This is to evaluate Bcl-3 expression level within each tumor and preliminarily examine the ability of Bcl-3 to predict response to TMZ and the efficacy of adding ACZ.

Feasibility to be determined based on ability to complete accrual to the study

University of Chicago

Wounds and Injuries

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Syndrome

Congenital Abnormalities

Cerebrospinal Fluid Leak

Spinal Dysraphism

Neural Tube Defects

Spina Bifida Occulta

Nervous System Malformations

Tethered Cord Syndrome

Split Spinal Cord Malformation

Lipomyelomeningocele

Spina Bifida

administration of Acetazolamide for 10 days following the surgery

Positioning the patient following surgery for 10 days

applying both Acetazolamide and prone positioning

Acetazolamide administration for 10 days adjust dosage with weight of the patient

prone positioning the patient for 10 days following the surgery

prone positioning

administration of acetazolamide and position the patient for 10 days following the surgery

Acetazolamide+ prone positioning

Farideh Nejat, MD

Shima Shahjouei, Student

* Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.
* Sample size: 144
* intervention groups:

  * Group A: Acetazolamide administration for 10 days
  * Group B: prone positioning for 10 days
  * Group C: Acetazolamide administration and prone positioning for 10 days
  * Group D: no intervention
* Period of study: Autumn 2012 to the end of winter of 2015

The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:

* Group A: Acetazolamide administration for 10 days
* Group B: prone positioning for 10 days
* Group C: Acetazolamide administration and prone positioning for 10 days
* Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.

Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence

Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection and Wound Dehiscence in Children.

leakage of CSF during 1 months following surgery

collection of the CSF beneath the skin during 1 month following the surgery

dehiscence of the surgical wound during the first month following surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	NCT05470283	Tumor Metastatic Mela... Melanoma	OBX-115 Acetazolamide Cyclophosphamid... Furosemide Mesna Fludarabine Pho...	18 Years -	M.D. Anderson Cancer Center
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma	NCT03011671	Malignant Gliom...	Acetazolamide Temozolomide	18 Years -	University of Chicago
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence	NCT01867268	Fibrolipoma of ... Lipomyelomening... Split Cord Malf... Dermal Sinus Tethered Cord S... Tumor	Acetazolamide prone positioni... Acetazolamide+ ...	- 18 Years	Tehran University of Medical Sciences

Spots Global Cancer Trial Database for acetazolamide