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Monoclonal Antibodies

pharmacological study for Brain Tumor

Phase 2

Waitlist Available

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial uses a monoclonal antibody that finds and attaches to tumor cells, and then kills them with a tumor-killing substance, without harming normal cells. Researchers want to see if this is an effective treatment for central nervous system cancer or leptomeningeal metastases, and what side effects it may cause.

Eligible Conditions

Brain Tumor
Retinoblastoma
Skin Cancer
Sarcoma
Lung Cancer
Cancer
Neuroblastoma
Intraocular Melanoma
Ovarian Cancer
Small Intestine Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Response at 6 Months

Six-month Overall Survival

Secondary outcome measures

Number of Participants Evaluable for Toxicities

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296

82%

Fatigue

45%

Hot flashes

42%

Anorexia

39%

Constipation

27%

Pain

27%

Generalized muscle weakness

21%

Back pain

18%

Diarrhea

18%

Headache

18%

Hypertension

18%

Dizziness

18%

Nausea

15%

Weight loss

15%

Arthralgia

15%

Upper respiratory infection

12%

Abdominal pain

12%

Memory impairment

12%

Peripheral sensory neuropathy

12%

Hematuria

12%

Vomiting

12%

Fall

12%

Pain in extremity

12%

Urinary frequency

Dyspnea

Pelvic pain

Hyperglycemia

General disorders and administration site conditions - Other

Anxiety

Edema limbs

Breast pain

Alopecia

Ear pain

Flank pain

Urinary incontinence

White blood cell decreased

Renal and urinary disorders - Other

Investigations - Other

Cystitis noninfective

Fracture

Hypokalemia

Weight gain

Watering eyes

Paresthesia

Neoplasms benign, malignant and unspecified

Flu like symptoms

Arthritis

Bone pain

Cough

Urinary retention

Neutrophil count decreased

Small intestinal obstruction

Depression

Dyspepsia

Platelet count decreased

Confusion

Ileus

Skin and subcutaneous tissue disorders - Other

Skin infection

Non-cardiac chest pain

Blurred vision

Muscle weakness lower limb

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Enzalutamide, Mifepristone)

Treatment (Enzalutamide)

Not Randomized

Trial Design

1Treatment groups

Experimental Treatment

Group I: 131I-3F8Experimental Treatment5 Interventions

This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iodine I 131 monoclonal antibody 3F8

2003

Completed Phase 2

~110

131I-3F8

2006

Completed Phase 2

~80

DNA analysis

2007

Completed Phase 2

~6450

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,126 Total Patients Enrolled

Kim Kramer, MDStudy ChairMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this medication been federally approved for testing yet?

"This pharmacological study is considered to be safe, with a score of 2. This means that while there is some data supporting the safety of the medication, there is no data yet supporting its efficacy."

Answered by AI

Is this trial still recruiting new participants?

"Unfortunately, this study is not recruiting patients at the moment. The trial was originally posted on January 1st, 2006 and was last updated almost 16 years ago on October 28th, 2022. Although this specific trial isn't looking for new participants, there are 3,544 other clinical trials that are currently seeking candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer

2006. "Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00445965.