Is NCT04449549 recruiting in Bethesda, MD?

Yes, NCT04449549 is currently recruiting participants at its Bethesda, MD location. This neoplasms clinical trial is actively enrolling qualified participants.

How do I join the neoplasms clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Neoplasms Clinical Trial in Bethesda, MD

About This Neoplasms Study in Bethesda

Background: People with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see if these drugs together can make rare cancers shrink or stop growing. Objective: To learn if nilotinib and paclitaxel will benefit people with rare cancers. Eligibility: People age 18 and older who have a rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: Participants will be screened with medical history and physical exam. They will have blood and urine tests. They will have a pregnancy test if needed. They will have an electrocardiogram to check their heart. They will have imaging scans to measure their tumors. Participants will repeat the screening tests during the study. Participants will receive nilotinib and paclitaxel. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle. Participants will keep a medicine diary. They will track when they take the study drugs and any side effects they may have. Participants may have optional tumor biopsies. Participants can stay on the study until their disease gets worse or they have intolerable side effects. Participants will have a follow-up phone call about 30 days after taking the last dose of study drugs.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Patients must have histologically confirmed rare solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist. The list of eligible rare tumors can be found below\*\*. With Amendment G (v 6-17-24), eligibility will be limited to patients with adult granulosa cell ovarian cancer, clear cell ovarian cancer, anal cancer, or Ewing sarcoma.Patients must have measurable and evaluable disease.

Age \>= 18 years.

ECOG performance status \<= 2.

Patients must have normal organ and marrow function as defined below:

Absolute neutrophil count \>=1,500/mcL

Platelets \>=100,000/mcL

Total bilirubin \<=1.5 X institutional ULN

AST(SGOT)/ALT(SGPT) \<=3 X institutional upper limit of normal; \<= 5.0 x ULN in patients with liver metastases

creatinine \<=1.5 X institutional ULN OR

creatinine clearance \>=60 mL/min/1.73 m\^2 for patients with creatinine levels \>1.5 mg/dL

Nilotinib and paclitaxel have both been assigned to pregnancy category D by the FDA. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration.

Patients must have completed radiation therapy or major surgery \>= 3 weeks, or biologic therapy or chemotherapy \>= 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosoureas and mitomycin C) prior to entering the study. Patients must be \>= 2 weeks since any prior administration of a study drug in a Phase 0 or equivalent study and be \>= 1 week from palliative radiation therapy (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI s discretion). Patients must have recovered to eligibility levels from prior toxicity or adverse events. Treatment with bisphosphonates is permitted.

Biopsies are optional on this study. In lieu of baseline biopsies, patients are encouraged to submit at registration archival tumor biopsy tissue from a previous research study or medical care providing it meets the minimum collection and preservations requirements outlined for the submission of archival tissue are:

Tissue must have been collected within 3 months prior to registration.

Patient must not have received any intervening therapy for their cancer since the collection of the tumor sample.

Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For these patients, an HIV viral load test must be completed within 28 days prior to enrollment.

Rare Tumor Eligibility List

Epithelial tumors of nasal cavity, sinuses, nasopharynx

Epithelial tumors of major salivary glands

Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location

Undifferentiated carcinoma of gastrointestinal (GI) tract

Adenocarcinoma with variants of small intestine

Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas)

Fibromixoma and low-grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary

Rare Pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma

Intrahepatic cholangiocarcinoma

Extrahepatic cholangiocarcinoma and bile duct tumors

Sarcomatoid carcinoma of lung

Bronchoalveolar carcinoma lung (a.k.a. adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma)

Non-epithelial tumors of the ovary

Trophoblastic tumor

Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder

Cell tumor of the testes and extragonadal germ tumors

Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis

Squamous cell carcinoma variants of the genitourinary (GU) system

Spindle cell carcinoma of kidney, pelvis, ureter

Adenocarcinoma with variants of GU system (excluding prostate cancer)

Odontogenic malignant tumors

Pancreatic neuroendocrine tumor (PNET)

Neuroendocrine carcinoma including carcinoid of the lung

Pheochromocytoma, malignant

Paraganglioma

Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex

Desmoid tumors

Peripheral nerve sheath tumors and NF1-related tumors

Malignant giant cell tumors

Adrenal cortical tumors

Tumor of unknown primary (Cancer of Unknown Primary; CuP)

Not Otherwise Categorized (NOC) Rare Tumors

Adenoid cystic carcinoma

Vulvar cancer

MetaPLASTIC carcinoma (of the breast)

Gastrointestinal stromal tumor (GIST)

Perivascular epithelioid cell tumor (PEComa)

Apocrine tumors/Extramammary Paget s Disease

Peritoneal mesothelioma

Basal cell carcinoma

Clear cell cervical cancer

Esthenioneuroblastoma

Endometrial carcinosarcoma (malignant mixed Mullerian tumors)

Clear cell endometrial cancer

Clear cell ovarian cancer

Gestational trophoblastic disease (GTD)

Gallbladder cancer

Small cell carcinoma of the ovary, hypercalcemic type

Angiosarcoma

High-grade neuroendocrine carcinoma

Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)

Anal cancer

Merkel cell carcinoma

Pleural Mesothelioma

Sarcoma (bone \& soft tissue)

Thymic Carcinoma

Uterine Leiomyosarcoma

Papillary RCC

Exclusion Criteria

QTcF interval of \>=450 msec at study entry; congenital long QT syndrome

Sensory/motor neuropathy \>= Grade 2

Patients who are receiving any other investigational agents.

Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:

Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:

Evaluable or measurable disease outside the CNS

No metastases to brain stem, midbrain, pons, medulla, or cerebellum

No history of intracranial hemorrhage or spinal cord hemorrhage

No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.

No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1

Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:

Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and radiographic screening for the current study

No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1, Day 1

Screening CNS radiographic study \>=4 weeks from completion of radiotherapy and \>=2 weeks from discontinuation of corticosteroids

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.

Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic respiratory failure/congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study because nilotinib and paclitaxel have been assigned to pregnancy category D by the FDA. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT04449549) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neoplasms Treatment Options in Bethesda, MD

If you're searching for neoplasms treatment options in Bethesda, MD, this clinical trial (NCT04449549) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced neoplasms specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neoplasms clinical trials near you to find additional studies recruiting in your area.

Neoplasms Clinical Trial in Bethesda, MD

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