Is NCT06822010 recruiting in New Brunswick, NJ?

Yes, NCT06822010 is currently recruiting participants at its New Brunswick, NJ location. This urinary bladder cancer clinical trial is actively enrolling qualified participants.

How do I join the urinary bladder cancer clinical trial in New Brunswick?

To join this clinical trial in New Brunswick, 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 New Brunswick 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.

Urinary Bladder Cancer Clinical Trial in New Brunswick, NJ

About This Urinary Bladder Cancer Study in New Brunswick

This Phase II clinical trial, titled "A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)," aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.

Sponsor: Rutgers, The State University of New Jersey

Who Can Participate

Inclusion Criteria

Subjects must meet all of the following applicable inclusion criteria to participate in the study:

Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.

Patient is at least 18 years of age.

Naive or recurrent patients with High Grade Ta +/- CIS, non-invasive UTUC in the upper tract (pyelocalyceal system or ureter).

Histologic confirmation with biopsy is necessary.

All patients must undergo ureteroscopy with biopsy.

Non-Invasive Papillary Carcinoma (HGTa) lesions must be maximally ablated with ≤ 15 mm residual papillary disease in total. 4\. Favorable high-grade upper tract urothelial carcinoma (UTUC) as per American Urological Association (AUA) risk stratification below (except that multifocality, obstruction, ureteral involvement, bladder involvement will be allowed).

If the bladder is involved with NMIBC it should be treated prior to or during Gem/Jel treatments. 5\. Patients with ECOG (Eastern Cooperative Oncology Group) performance status \<3 (with Karnofsky \>40). 6\. Patients with life expectancy greater than 24 months at time of screening. 7. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis\*. 8\. Female Patients of childbearing potential\*\*, must have a negative serum pregnancy test at screening and must agree to use two acceptable \& effective methods of contraception\*\*\*, until 6 months post treatment 9. All sexually active male patients must agree to use a condom during intercourse, for at least 48 hours post each instillation. 10\. Male patients who have a partner that is a female of childbearing potential must agree to use two acceptable \& effective methods of contraception until 6 months post treatment. 11\. Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the investigator.

Exclusion Criteria

Invasive upper tract urothelial carcinoma (suspected cT2-4 on imaging) or lymphadenopathy (cN1-3) Bilateral disease Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial. 4\. Any other malignancy diagnosed within 2 years of trial entry with the exception of: a. Basal or squamous cell skin cancers, or b. Noninvasive cancer of the cervix, or c. Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period (basal or squamous cell skin cancers, noninvasive cancer of the cervix, prostate cancer under active surveillance, renal cancer under active surveillance). 4\. Administration not feasible via nephrostomy tube. 5. Inability to deliver the investigational drug to the pyelocalyceal system. 6. Patient has any other medical or mental condition(s) that make(s) his/her participation in the trial unadvisable in the opinion of the treating urologist. 7\. Patient has contraindication to mitomycin C (MMC )treatment, or known sensitivity to MMC. 8\. Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease). 9\. Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 30 days prior to Visit 1. 10\. Pregnant (positive serum pregnancy test), planning to become pregnant during the trial period, breast-feeding, or of childbearing potential and not practicing reliable contraception\*\*\*. \

In case of a symptomatic UTI the patient will be treated with a full course of antibiotics, and the instillation will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of the treatment is left to the discretion of the PI. \*\

Women of non-childbearing potential:

At least 12 months since the last menses, or

Without uterus and/or both ovaries, or

Has been surgically sterile for at least 6 months prior to trial drug administration.

Acceptable methods of birth control which are considered to have a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen/progesterone) oral contraceptives, intrauterine devices (IUDs-only hormonal), condoms with spermicide, sexual abstinence or vasectomized partner.

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 New Brunswick?

Yes, this clinical trial (NCT06822010) has an active research site in New Brunswick, NJ 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.

Urinary Bladder Cancer Treatment Options in New Brunswick, NJ

If you're searching for urinary bladder cancer treatment options in New Brunswick, NJ, this clinical trial (NCT06822010) 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 New Brunswick research site is actively enrolling participants for this clinical trial. You'll receive care from experienced urinary bladder cancer 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 urinary bladder cancer clinical trials near you to find additional studies recruiting in your area.

Urinary Bladder Cancer Clinical Trial in New Brunswick, NJ

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