Is NCT05232409 recruiting in Paramus, NJ?

Yes, NCT05232409 is currently recruiting participants at its Paramus, NJ location. This cancer metastatic clinical trial is actively enrolling qualified participants.

How do I join the cancer metastatic clinical trial in Paramus?

To join this clinical trial in Paramus, 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 Paramus 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.

Cancer Metastatic Clinical Trial in Paramus, NJ

Who Can Participate

Inclusion Criteria

for Dose escalation zeaxanthin monotherapy

Stage IV or unresectable stage 3 histologically confirmed solid tumor malignancy refractory to all standard therapies known to provide clinical benefit (unless the therapy is contraindicated or intolerable) in the opinion of the treating investigator for his/her tumor type. Subjects are not required to have received systemic therapies that have response rates under 20% with no associated survival benefit (for example DTIC chemotherapy and high dose Interleukin-2 in melanoma patients).

Age ≥ 18 years.

Performance status ECOG 0, 1 or 2

Adequate organ and marrow function as describe below:

Absolute neutrophil count ≥ 1,500/mcL

Platelets ≥ 100,000/mcl

Total bilirubin \< 1.5 x the normal institutional limits excluding patients with confirmed Gilbert's syndrome

AST (SGOT)/ALT (SPGT) ≤ 3 x the institutional upper limit of normal (ULN)

Creatinine ≤ 1.5 x the institutional upper limit of normal

Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Recommended methods of birth control are:

The consistent use of an approved hormonal contraception (birth control pill/patches, rings), An intrauterine device (IUD), Contraceptive injection (Depo-Provera), Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), Sexual abstinence (no sexual intercourse) or Sterilization.

Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy A Female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets at least one of the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Ability to understand and the willingness to sign a written informed consent.

Measurable disease is not required but evaluable disease is required.

Life expectancy of at least 3 months

Exclusion Criteria

for Dose escalation zeoxanthin monotherapy

Patients who have had chemotherapy or radiotherapy within 21 days prior to initiating study treatment or those who have not recovered to grade 1 or less from adverse events due to agents administered more than 21 days earlier excluding alopecia, gd 2 fatigue, gd 2 hearing loss from platinum agent, and endocrinopathies on stable replacement therapy. (Patients may not be receiving any other investigational agents or concomitant chemotherapy or radiation therapy. Hormonal therapy is not exclusionary.)

Patients with active brain metastases requiring palliation with steroids and not stable for at least 4 weeks post radiation therapy or surgery.

Leptomeningeal carcinomatosis

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

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

Patients with another primary malignancy not in remission for at least 3 years. Exceptions include nonmelanoma skin cancer, curatively treated localized prostate cancer with normal prostate specific antigen, low risk prostate cancer followed expectantly, stage I colorectal cancer resected, resected stage 1 breast cancer cervical carcinoma in situ on biopsy, melanoma in situ resected, or squamous intraepithelial lesion on PAP smear.

Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Women of child bearing potential must have a negative serum or urine pregnancy test prior to the first dose of study treatment

Inability to swallow pills. Inclusion Criteria for dose escalation zeoxanthin plus pembrolizumab

Stage IV or unresectable stage 3 histologically confirmed solid tumor malignancy for which pembrolizumab is FDA approved and progressed on prior PD-1 or PD-L1 therapy and if indicated for cancer type refractory to all standard therapies known to provide clinical benefit (unless the therapy is contraindicated or intolerable) in the opinion of the treating investigator for his/her tumor type. Subjects are not required to have received systemic therapies that have response rates under 20% with no associated survival benefit (for example DTIC chemotherapy and high dose Interleukin-2 in melanoma patients).

Patients must have had symptomatic or radiographic progression during or following treatment with a PD-1 or PD-L1 inhibitor. This is defined as imaging obtained subsequent to initiation of PD-1 or PD-L1 inhibitor demonstrating a new lesion that is consistent with metastasis or growth of a preexisting metastasis which the treating physician felt reflected tumor progression and therefore discontinued the immunotherapy. . Symptomatic progression refers to development of worsening bone pain related to bone metastasis that cannot be accurately measured on imaging and for which the treating physician had discontinued the immunotherapy.

Age ≥ 18 years.

Performance status ECOG 0, 1or 2.

Adequate organ and marrow function as describe below:

Absolute neutrophil count ≥ 1,500/mcL

Platelets ≥ 100,000/mcl

Total bilirubin) ≤ 1.5 x normal institutional limits excluding patients with confirmed Gilbert's syndrome

AST (SGOT)/ALT (SPGT) ≤ 3 x institutional upper limit of normal

Creatinine ≤ 1.5 x the institutional upper limit of normal

Has not undergone a hysterectomy or bilateral oophorectomy

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Ability to understand and the willingness to sign a written informed consent.

Measurable disease is not required but evaluable disease is required

Life expectancy of at least 3 months Exclusion Criteria for zeoxanthin plus pembrolizumab

Patients who have had immunotherapy, chemotherapy or radiotherapy within 21 days prior to entering the study or those who have not recovered to grade1 or lower from adverse events due to agents administered more than 21 days earlier excluding alopecia, gd 2 fatigue, gd 2 hearing loss from platinum agent, and endocrinopathies on stable replacement therapy.

Prior grade 3 or greater immune mediated toxicity related to PD-1 or PD-L1 inhibitor. Prior grade 2 or higher colitis, diarrhea, hepatitis, neurologic, cardiac, immune mediated toxicity related to PD-1 or PD-L1 inhibitor. Exceptions include vitiligo and controlled endocrinopathies.

Patients may not be receiving any other investigational agents or concomitant chemotherapy or radiation therapy.

Patients taking oral steroids at or greater than the equivalent of 10 milligrams of oral prednisone daily.

Inability to swallow pills.

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

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

Patients with active brain metastases requiring palliation with steroids not stable for at least 4 weeks post radiation therapy or surgery

Leptomeningeal carcinomatosis

Patients with another primary malignancy not in remission for at least 3 years. Exceptions include non-melanoma skin cancer, curatively treated localized prostate cancer with normal prostate specific antigen, low risk prostate cancer followed expectantly, resected stage 1 colon cancer, resected stage 1 breast cancer, cervical carcinoma in situ on biopsy, melanoma in situ resected, or squamous intraepithelial lesion on PAP smear.

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 Paramus?

Yes, this clinical trial (NCT05232409) has an active research site in Paramus, 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.

Cancer Metastatic Treatment Options in Paramus, NJ

If you're searching for cancer metastatic treatment options in Paramus, NJ, this clinical trial (NCT05232409) 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 Paramus research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cancer metastatic 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 cancer metastatic clinical trials near you to find additional studies recruiting in your area.

Cancer Metastatic Clinical Trial in Paramus, NJ

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