Blood Stem Cell transplantation with low dose chemo/radiotherapy for patients with High-Risk solid tumors using related identical donors or 50% compatible donors

Phase 1

Active, not recruiting

• Conditions: solid tumors metastatic or relapsed, resistant/refractory to conventional therapy; MedDRA version: 20.0Level: LLTClassification code 10006190Term: Breast cancer invasive NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 25.1Level: LLTClassification code 10033612Term: Pancreatic carcinoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10017760Term: Gastric cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002464-27-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-27
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-Histologically or cytologically proven diagnosis of renal cell cancer, neurendocrine cancer, pancreatic cancer, rhinopharyngeal lymphoepithelioma, malignant melanoma, soft-tissue sarcoma, ovarian carcinoma, gastric carcinoma, germ cell tumors, breast cancer, colorectal cancer with evidence of unresectable, locally recurrent, or metastatic disease. Locally recurrent disease must not be amenable to resection or radiation therapy with curative intent
-Recurrent/refractory disease after primary treatment and deemed not suitable for standard therapy. Metastatic disease not eligible for standard therapy-potentially curative or able to extend life expectancy.

-Prior treatment with chemotherapy as follows: receipt of adjuvant chemotherapy with RECIST defined disease progression documented during treatment or disease relapse within 6 months of last treatment, or receipt of chemotherapy in the first-line advanced disease setting with RECIST defined disease stable or progression documented during treatment, or, if the patient completed treatment with objective disease response, documented disease stable or progression after discontinuing treatment. Patients entering the study on the basis of this criterion may have also previously received neoadjuvant or adjuvant treatment with chemotherapy.

-Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
-Male or female.
-Patients age > 18 and < 70 years.
-ECOG performance status 0-2.
-Resolution of all acute toxic effects of prior therapy or surgical procedures to grade =1 (except alopecia).

-Life expectancy >3 months.
-A fully HLA-identical or alternatively an HLA haploidentical related donor is available.
-The definitions of minimum adequacy for organ function required prior to study entry are as follows:
. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), or AST and ALT =5 x ULN if liver function abnormalities are due to underlying malignancy
. Total serum bilirubin =1.5 x ULN
. Absolute neutrophil count (ANC) =1500/µL
. Platelets =100,000/µL
. Haemoglobin =9.0 g/dL
. Serum creatinine =1.5 x ULN
-Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
-Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Uncontrolled CNS involvement with disease
-Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
-Females who are pregnant
-Organ dysfunction defined as follows:
¿Cardiac ejection fraction <30% or uncontrolled cardiac failure
¿Pulmonary: DLCO <40% predicted
¿Liver: elevation of bilirubin to > 1.5 x ULN and/or transaminases >5x the upper limit of normal
¿Renal: Serum creatinine >1.5 x ULN
-ECOG performance status >2
-Patients with poorly controlled hypertension on multiple antihypertensives
-Documented fungal disease that is progressive despite treatment
-Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis
-Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
-Patients may not be receiving any other investigational agents.
-History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
-Any previous or current malignancy at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix and adequately treated basal or squamous cell carcinoma of the skin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified